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    Clinical Trial Results:
    Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, the VERTIS CV Study

    Summary
    EudraCT number
    		 2013-002518-11
    Trial protocol
    		 SE   NL   GB   IT   ES   BG   PL   GR   HR   SK   LT   LV   CZ   HU  
    Global end of trial date
    27 Dec 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Mar 2021
    First version publication date
    24 Jan 2021
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    • Correction of full data set
    Updates to this posting on EudraCT to align with changes to the results disclosure finalized on www.clinicaltrials.gov.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    8835-004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01986881
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 B1521021: Pfizer Protocol Number, MK-8835-004: Merck Protocol Number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Dec 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Overall Cardiovascular Study: To demonstrate the non-inferiority of ertugliflozin compared with placebo on the time to first occurrence of the composite endpoint of MACE: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Three glycemic Sub-Studies: To assess the effect on hemoglobin A1c (A1C) of 15 mg ertugliflozin as compared with placebo. To assess the effect on A1C of 5 mg ertugliflozin as compared with placebo.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research. Participants who met glycemic rescue criteria received glycemic rescue medication.
    Background therapy
    		 For the 3 Glycemic sub-studies: 1. A sub-study in participants receiving background insulin with or without metformin 2. A sub-study in participants receiving background sulfonylurea (SU) monotherapy 3. A sub-study in participants receiving background metformin with SU.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Nov 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 592
    Country: Number of subjects enrolled
    Australia: 97
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 108
    Country: Number of subjects enrolled
    Canada: 184
    Country: Number of subjects enrolled
    Colombia: 55
    Country: Number of subjects enrolled
    Georgia: 833
    Country: Number of subjects enrolled
    Hong Kong: 98
    Country: Number of subjects enrolled
    Israel: 151
    Country: Number of subjects enrolled
    Korea, Republic of: 65
    Country: Number of subjects enrolled
    Mexico: 76
    Country: Number of subjects enrolled
    New Zealand: 76
    Country: Number of subjects enrolled
    Philippines: 112
    Country: Number of subjects enrolled
    Russian Federation: 440
    Country: Number of subjects enrolled
    Serbia: 65
    Country: Number of subjects enrolled
    South Africa: 377
    Country: Number of subjects enrolled
    Taiwan: 62
    Country: Number of subjects enrolled
    Thailand: 35
    Country: Number of subjects enrolled
    Turkey: 35
    Country: Number of subjects enrolled
    Ukraine: 735
    Country: Number of subjects enrolled
    United States: 1629
    Country: Number of subjects enrolled
    Bulgaria: 158
    Country: Number of subjects enrolled
    Croatia: 163
    Country: Number of subjects enrolled
    Czechia: 43
    Country: Number of subjects enrolled
    Greece: 35
    Country: Number of subjects enrolled
    Hungary: 249
    Country: Number of subjects enrolled
    Italy: 35
    Country: Number of subjects enrolled
    Latvia: 18
    Country: Number of subjects enrolled
    Lithuania: 32
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Poland: 866
    Country: Number of subjects enrolled
    Romania: 280
    Country: Number of subjects enrolled
    Slovakia: 111
    Country: Number of subjects enrolled
    Sweden: 61
    Country: Number of subjects enrolled
    United Kingdom: 363
    Worldwide total number of subjects
    8246
    EEA total number of subjects
    2058
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    4095
    From 65 to 84 years
    4122
    85 years and over
    29

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study included participants in 34 countries at 548 study centers (Overall Cardiovascular Study).

    Pre-assignment
    Screening details
    		 1. Diagnosis of Type 2 diabetes mellitus by American Diabetes Association (ADA) criteria 2. Hemoglobin A1c (A1C) at the start of study participation of 7.0-10.5% 3. On stable allowable anti-hyperglycemic agents (AHA) or on no background AHA for at least 8 weeks prior to study participation 4. Body Mass Index (BMI) > = to 18.0 kg/m^2

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study)
    Arm description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ertugliflozin
    Investigational medicinal product code
    Other name
    MK-8835-004, PF-04971729, Steglatro
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years

    Arm title
    		 Ertugliflozin 15 mg (Overall Cardiovascular Study)
    Arm description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ertugliflozin
    Investigational medicinal product code
    Other name
    MK-8835-004, PF-04971729, Steglatro
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ertugliflozin, 15 mg, administered orally once daily for up to approximately 6 years

    Arm title
    		 Placebo (Overall Cardiovascular Study)
    Arm description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to Ertugliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo to ertugliflozin administered orally once daily for up to 6.1 years

    Number of subjects in period 1
    		Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Started
    2752
    2747
    2747
    Enrollment in the Insulin/Met. Sub-Study
    348 [1]
    370 [2]
    347 [3]
    Enrollment in the Sulfonylurea Sub-Study
    55 [4]
    54 [5]
    48 [6]
    Enrollment in the Metformin/SU Sub-Study
    100 [7]
    113 [8]
    117 [9]
    Completed
    2422
    2401
    2389
    Not completed
    330
    346
    358
         Physician decision
    7
    4
    6
         Consent withdrawn by subject
    41
    60
    45
         Study Site terminated
    2
    2
    3
         Death
    228
    233
    247
         Unknown
    1
    2
    2
         Lost to follow-up
    51
    44
    55
         Subject Moved
    -
    1
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Enrollment for the individual sub-study only.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ertugliflozin 5 mg (Overall Cardiovascular Study)
    Reporting group description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Ertugliflozin 15 mg (Overall Cardiovascular Study)
    Reporting group description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Placebo (Overall Cardiovascular Study)
    Reporting group description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years

    Reporting group values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) Total
    Number of subjects
    		 2752 2747 2747 8246
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 1348 1371 1376 4095
        From 65-84 years
    		 1394 1368 1360 4122
        85 years and over
    		 10 8 11 29
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 64.3 ( 8.2 ) 64.4 ( 8.0 ) 64.4 ( 8.0 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 801 832 844 2477
        Male
    		 1951 1915 1903 5769
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 13 8 17 38
        Asian
    		 187 149 162 498
        Native Hawaiian or Other Pacific Islander
    		 4 10 15 29
        Black or African American
    		 91 75 69 235
        White
    		 2390 2436 2414 7240
        More than one race
    		 67 69 70 206
        Unknown or Not Reported
    		 0 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 353 347 343 1043
        Not Hispanic or Latino
    		 2390 2392 2399 7181
        Unknown or Not Reported
    		 9 8 5 22
    Fasting Plasma Glucose (FPG)
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 176.1 ( 52.5 ) 174.8 ( 51.6 ) 173.6 ( 49.4 ) -
    Body Weight
    Units: Kilograms
        arithmetic mean (standard deviation)
    		 91.9 ( 18.4 ) 91.6 ( 18.6 ) 91.9 ( 18.3 ) -
    Serum Creatinine
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 0.992 ( 0.278 ) 0.985 ( 0.277 ) 0.991 ( 0.281 ) -
    Sitting Systolic Blood Pressure (SBP)
    Units: mmHg
        arithmetic mean (standard deviation)
    		 133.7 ( 13.7 ) 133.2 ( 13.8 ) 133.1 ( 13.9 ) -
    Sitting Diastolic Blood Pressure (DBP)
    Units: mmHg
        arithmetic mean (standard deviation)
    		 76.8 ( 8.5 ) 76.7 ( 8.2 ) 76.4 ( 8.7 ) -
    Hemoglobin A1C (A1C)
    Units: A1C Percentage
        arithmetic mean (standard deviation)
    		 8.3 ( 1.0 ) 8.2 ( 1.0 ) 8.2 ( 0.9 ) -
    Estimated Glomerular Filtration Rate (eGFR)
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    		 76.0 ( 20.8 ) 76.2 ( 20.9 ) 75.7 ( 20.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Ertugliflozin 5 mg (Overall Cardiovascular Study)
    Reporting group description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Ertugliflozin 15 mg (Overall Cardiovascular Study)
    Reporting group description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Placebo (Overall Cardiovascular Study)
    Reporting group description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years

    Subject analysis set title
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Placebo (Insulin +/- Metformin Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Placebo (Insulin +/- Metformin Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Placebo (Insulin +/- Metformin Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    Placebo (Sulfonylurea Monotherapy Glycemic Sub-study)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Subject analysis set title
    All Ertugliflozin (Overall Cardiovascular Study)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Ertugliflozin 5 mg or 15 mg, administered orally, once daily, for up to approximately 6 years

    Primary: Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (Overall Cardiovascular Study)

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    End point title
    		 Time to First Occurrence of MACE (Composite Endpoint of Major Adverse Cardiovascular Events [Cardiovascular Death, Non-fatal Myocardial Infarction or Non-fatal Stroke]) (Overall Cardiovascular Study)
    End point description
    Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke. Person-years was calculated as the sum of participants’ time to first event or time to censoring (the earliest of participants’ end of study date, death date, last contact date, or 365 days after the last dose). The analysis population included all randomized into the study and who received at least 1 dose of study medication.
    End point type
    Primary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    5493
    Units: Events per 100 Person-years
        number (not applicable)
    3.64
    4.16
    4.01
    3.90
    Statistical analysis title
    		 Non-inferiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.001 [2]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95.6%
         sides
    2-sided
         lower limit
    		 0.773
         upper limit
    		 1.065
    Notes
    [1] - 1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.
    [2] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Non-inferiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v Ertugliflozin 15 mg (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    P-value
    		 = 0.002 [4]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95.6%
         sides
    2-sided
         lower limit
    		 0.887
         upper limit
    		 1.211
    Notes
    [3] - 1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.
    [4] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Non-inferiority Cox Proportional Hazards Model
    Statistical analysis description
    1-sided p-value and the non-inferiority margin is a hazard ratio of 1.3.
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8238
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [5]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95.6%
         sides
    2-sided
         lower limit
    		 0.848
         upper limit
    		 1.114
    Notes
    [5] - Model included treatment as an explanatory factor and cohort category as a stratification factor.

    Primary: Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Baseline Hemoglobin A1C (A1C) (Insulin With or Without Metformin Add-on Glycemic Sub-study) [6]
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or performed for this primary endpoint.
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    346
    367
    346
    Units: A1C Percentage
        arithmetic mean (standard deviation)
    8.45 ( 0.944 )
    8.38 ( 0.985 )
    8.39 ( 0.928 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least 1 dose of study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Primary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: A1C Percentage
        least squares mean (confidence interval 95%)
    -0.77 (-0.86 to -0.67)
    -0.84 (-0.93 to -0.74)
    -0.19 (-0.29 to -0.09)
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [7]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.71
         upper limit
    		 -0.44
    Notes
    [7] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin + metformin) and "Time" was a categorical variable
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [8]
    Method
    		 cLDA Model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.78
         upper limit
    		 -0.51
    Notes
    [8] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, stratum, and the interaction of time by treatment. The stratum was (insulin alone or insulin + metformin) and "Time" was a categorical variable

    Primary: Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Baseline Hemoglobin A1C (A1C) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study) [9]
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects the Week 0 A1C. The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, and had a measurement of the analysis endpoint at Baseline.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or performed for this primary endpoint.
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    54
    54
    48
    Units: A1C Percentage
        arithmetic mean (standard deviation)
    8.27 ( 0.999 )
    8.39 ( 1.019 )
    8.21 ( 1.169 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Sulfonyl Monotherapy Glycemic Sub-study, received at least 1 dose of study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Primary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: A1C Percentage
        least squares mean (confidence interval 95%)
    -0.91 (-1.17 to -0.65)
    -0.78 (-1.06 to -0.51)
    -0.56 (-0.84 to -0.27)
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.063 [10]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 0.02
    Notes
    [10] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment. .
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.247 [11]
    Method
    		 cLDA Model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 0.16
    Notes
    [11] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.

    Primary: Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Baseline Hemoglobin A1C (A1C) (Metformin With Sulfonylurea Add-on Glycemic Sub-study) [12]
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This baseline reflects Week 0 A1C. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and had an assessment for the analysis endpoint at Baseline.
    End point type
    Primary
    End point timeframe
    Baseline
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses were planned or performed for this primary endpoint.
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    99
    113
    116
    Units: A1C Percentage
        arithmetic mean (standard deviation)
    8.39 ( 0.960 )
    8.30 ( 0.963 )
    8.27 ( 0.994 )
    No statistical analyses for this end point

    Primary: Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin with Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Metformin with Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Primary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: A1C Percentage
        least squares mean (confidence interval 95%)
    -0.89 (-1.06 to -0.71)
    -0.98 (-1.14 to -0.82)
    -0.23 (-0.39 to -0.06)
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [13]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.89
         upper limit
    		 -0.43
    Notes
    [13] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [14]
    Method
    		 cLDA Model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 -0.53
    Notes
    [14] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR, and the interaction of time by treatment.

    Secondary: Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) - On-Study Approach (Overall Cardiovascular Study)

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    End point title
    		 Time to Occurrence of Cardiovascular (CV) Death or Hospitalization for Heart Failure (HHF) - On-Study Approach (Overall Cardiovascular Study)
    End point description
    Time to the occurrence of any of the following adjudicated components of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)) or hospitalization for heart failure. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to event or time to censoring (the earliest of participants’ end of study date, death date, or last contact date). The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    2.36
    2.33
    2.66
    2.34
    Statistical analysis title
    		 Superiority Cox Propotional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.188 [15]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.735
         upper limit
    		 1.068
    Notes
    [15] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Propotional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.15 [16]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.725
         upper limit
    		 1.057
    Notes
    [16] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Propotional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.108 [17]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.034
    Notes
    [17] - Model included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to Occurrence of Cardiovascular Death - On-study Approach (Overall Cardiovascular Study)

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    End point title
    		 Time to Occurrence of Cardiovascular Death - On-study Approach (Overall Cardiovascular Study)
    End point description
    Time to the occurrence of cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to CV death or time to censoring (the earliest of participants’ end of study date or date last known to be alive). The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 person-years
        number (not applicable)
    1.77
    1.74
    1.90
    1.76
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.494 [18]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.154
    Notes
    [18] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.417 [19]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.739
         upper limit
    		 1.139
    Notes
    [19] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.385 [20]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.767
         upper limit
    		 1.113
    Notes
    [20] - Model included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Time to First Occurrence of the Renal Composite: the Composite of Renal Death, Renal Dialysis/Transplant, or Doubling of Serum Creatinine From Baseline (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    Renal composite endpoint was defined as a composite of renal death, renal dialysis/transplant, or doubling of serum creatinine from baseline. The on-study approach included events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to first event or time to censoring (the earliest of participants’ end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    0.87
    0.98
    1.15
    0.93
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.065 [21]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.568
         upper limit
    		 1.028
    Notes
    [21] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.258 [22]
    Method
    		 Cox Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.638
         upper limit
    		 1.137
    Notes
    [22] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.081 [23]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95.8%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.036
    Notes
    [23] - Model included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Time to First Occurrence of Hospitalization for Heart Failure (HHF) (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    Time to the first occurrence of heart failure requiring hospitalization (adjudicated). The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to first event or time to censoring (the earliest of participants’ end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    0.75
    0.72
    1.05
    0.73
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.028 [24]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.524
         upper limit
    		 0.964
    Notes
    [24] - Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016 [25]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.502
         upper limit
    		 0.932
    Notes
    [25] - Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [26]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.539
         upper limit
    		 0.902
    Notes
    [26] - Hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Time to First Occurrence of MACE Plus (Composite Endpoint of Cardiovascular Death, Non-fatal Myocardial Infarction, Non-fatal Stroke or Hospitalization for Unstable Angina) (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    Time to the first occurrence of any of the following adjudicated components 4-point MACE: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke, and hospitalization for unstable angina pectoris. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to first event or time to censoring (the earliest of participants’ end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date and the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    4.42
    4.67
    4.92
    4.54
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.123 [27]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.785
         upper limit
    		 1.029
    Notes
    [27] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.45 [28]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.831
         upper limit
    		 1.086
    Notes
    [28] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.183 [29]
    Method
    		 Cox proportional hazards model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.823
         upper limit
    		 1.038
    Notes
    [29] - Model included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction - On-Study Approach (Overall Cardiovascular Study)

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    End point title
    		 Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction - On-Study Approach (Overall Cardiovascular Study)
    End point description
    Time to First Occurrence of Fatal or Non-fatal Myocardial Infarction. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants' time to first event or time to censoring (the earliest of participants' end of study date, death date, or last contact date). The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    1.55
    2.00
    1.70
    1.77
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.416 [30]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.727
         upper limit
    		 1.141
    Notes
    [30] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.676 [31]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.861
         upper limit
    		 1.259
    Notes
    [31] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.139 [32]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.949
         upper limit
    		 1.451
    Notes
    [32] - Model included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Time to First Occurrence of Fatal or Non-fatal Stroke (FNF Stroke) (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    Time to the first occurrence of fatal and no-fatal stroke. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to first event or time to censoring (the earliest of participants’ end of study date, death date, or last contact date). The on-study approach included events that occurred between the randomization date nd the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    0.92
    1.04
    0.93
    0.98
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Statistical analysis description
    Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.953 [33]
    Method
    		 Cox proportional hazards model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.736
         upper limit
    		 1.334
    Notes
    [33] - A two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.663 [34]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.365
    Notes
    [34] - Hazard ratio, CI, and 2-sided p-value comparing All Ertugliflozin versus Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Statistical analysis description
    Hazard ratio, confidence interval, and two-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that includes treatment as an explanatory factor and cohort category as a stratification factor.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.415 [35]
    Method
    		 Cox proportional hazards model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.845
         upper limit
    		 1.505
    Notes
    [35] - A two-sided p-value compared Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Time to Occurrence of Death From Any Cause (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    Time to the first occurrence of death from any cause. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date. Person-years was calculated as the sum of participants’ time to first event or time to censoring (the earliest of participants’ end of study date, death date, or last contact date, or date last known to be alive). The on-study approach included events that occurred between the randomization date and the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    2.42
    2.46
    2.62
    2.44
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.363 [36]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.771
         upper limit
    		 1.1
    Notes
    [36] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.463 [37]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.784
         upper limit
    		 1.117
    Notes
    [37] - Model included treatment as an explanatory factor and cohort category as a stratification factor.
    Statistical analysis title
    		 Superiority Cox Proportional Hazards Model
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [38]
    P-value
    		 = 0.34 [39]
    Method
    		 Cox Proportional Hazards Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.797
         upper limit
    		 1.081
    Notes
    [38] - Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor. The on-study approach included confirmed events that occurred between the randomization date and the on-study censor date.
    [39] - Hazard ratio, CI, and 2-sided p-value comparing Ertugliflozin vs Placebo, based on the stratified Cox proportional hazards model that included treatment as an explanatory factor and cohort category as a stratification factor.

    Secondary: Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Andersen-Gill Model for Total MACE (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    All events (first and recurrent) of the composite of MACE (3-point major adverse cardiovascular events: cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI, and non-fatal stroke) were assessed using an Andersen-Gill model. The on-study approach included events that occurred between the randomization date and the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Events per 100 Person-years
        number (not applicable)
    4.35
    4.91
    4.59
    4.63
    Statistical analysis title
    		 Superiority Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.828
         upper limit
    		 1.085
    Statistical analysis title
    		 Superiority Analysis
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [40]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.898
         upper limit
    		 1.131
    Notes
    [40] - Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach includes confirmed events that occurred between the randomization date and the on-study censor date.
    Statistical analysis title
    		 Superiority Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.937
         upper limit
    		 1.219

    Secondary: Andersen-Gill Model for All Cardiovascular Death or Hospitalizations for Heart Failure (On-Study Approach) (Overall Cardiovascular Study)

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    End point title
    		 Andersen-Gill Model for All Cardiovascular Death or Hospitalizations for Heart Failure (On-Study Approach) (Overall Cardiovascular Study)
    End point description
    All events (first and recurrent) of the composite of CV death and HHF were assessed using an Andersen-Gill model. Person-years were calculated as the sum of time from randomization to end of follow-up. Person-years were calculated as the sum of time from randomization to end of follow-up. The on-study approach included events that occurred between the randomization date and the on-study censor date. The analysis population included all randomized participants.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    5499
    Units: Rate/100 Event-years
        number (not applicable)
    2.92
    2.71
    3.42
    2.82
    Statistical analysis title
    		 Superiority Andersen-Gill Model Analysis
    Statistical analysis description
    Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5499
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.725
         upper limit
    		 1.001
    Statistical analysis title
    		 Superiority Andersen-Gill Model Analysis
    Statistical analysis description
    Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5494
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.673
         upper limit
    		 0.935
    Statistical analysis title
    		 Superiority Andersen-Gill Model Analysis
    Statistical analysis description
    Ertugliflozin vs Placebo, based on the Andersen-Gill model for the recurrent events at the end of study. The on-study approach included confirmed events that occurred between randomization date and the on-study censor date.
    Comparison groups
    Placebo (Overall Cardiovascular Study) v All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects included in analysis
    8246
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.716
         upper limit
    		 0.945

    Secondary: Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Hemoglobin A1C (A1C) at Week 18 - Excluding Rescue Approach (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2745
    2747
    2742
    Units: A1C Percentage
        least squares mean (confidence interval 95%)
    -0.70 (-0.73 to -0.67)
    -0.72 (-0.75 to -0.69)
    -0.22 (-0.25 to -0.19)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5487
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [41]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 -0.44
    Notes
    [41] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [42]
    Method
    		 cLDA Model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.46
    Notes
    [42] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in A1C at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in A1C at Week 52 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: A1C Percentage
        least squares mean (confidence interval 95%)
    -0.69 (-0.73 to -0.65)
    -0.67 (-0.71 to -0.63)
    -0.19 (-0.23 to -0.15)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [43]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.55
         upper limit
    		 -0.45
    Notes
    [43] - Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [44]
    Method
    		 Constrained Longitudinal Data Analysis
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.54
         upper limit
    		 -0.43
    Notes
    [44] - Model included fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in A1C at Month 24 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 24 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: A1C Percentage
        least squares mean (confidence interval 95%)
    -0.48 (-0.52 to -0.43)
    -0.46 (-0.50 to -0.41)
    -0.08 (-0.14 to -0.03)
    Statistical analysis title
    		 Constrained longitudinal data analysis (cLDA)
    Statistical analysis description
    Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [45]
    Method
    		 cLDA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.32
    Notes
    [45] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Statistical analysis title
    		 Constrained longitudinal data analysis (cLDA)
    Statistical analysis description
    Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [46]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.45
         upper limit
    		 -0.3
    Notes
    [46] - Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.

    Secondary: Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in A1C at Month 36 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 36 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1590
    1574
    1501
    Units: A1C Percentage
        arithmetic mean (confidence interval 95%)
    -0.42 (-0.47 to -0.37)
    -0.38 (-0.43 to -0.33)
    -0.04 (-0.10 to 0.01)
    No statistical analyses for this end point

    Secondary: Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in A1C at Month 48 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 48 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one assessment for specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    875
    859
    781
    Units: A1C Percentage
        arithmetic mean (confidence interval 95%)
    -0.39 (-0.46 to -0.32)
    -0.38 (-0.45 to -0.30)
    0.00 (-0.08 to 0.08)
    No statistical analyses for this end point

    Secondary: Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in A1C at Month 60 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 60 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    526
    527
    477
    Units: A1C Percentage
        arithmetic mean (confidence interval 95%)
    -0.25 (-0.35 to -0.15)
    -0.28 (-0.38 to -0.18)
    -0.10 (-0.20 to 0.00)
    No statistical analyses for this end point

    Secondary: Change from Baseline in A1C at Month 72 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in A1C at Month 72 (Overall Cardiovascular Study)
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. This change from baseline reflects the Month 72 A1C minus the Week 0 A1C. A negative number indicates a reduction in A1C level. Participants who met glycemic rescue criteria received glycemic rescue medication.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    13
    12
    9
    Units: A1C Percentage
        arithmetic mean (confidence interval 95%)
    -0.35 (-0.89 to 0.20)
    -0.13 (-0.99 to 0.74)
    0.24 (-0.74 to 1.23)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <7% (<53mmol/Mol) at Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53mmol/Mol) at Week 18 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2544
    2520
    2527
    Units: Percentage of Participants
        number (not applicable)
    28.4
    28.2
    15.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 52 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2363
    2347
    2311
    Units: Percentage of Participants
        number (not applicable)
    28.3
    29.0
    17.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 24 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1570
    1541
    1496
    Units: Percentage of Participants
        number (not applicable)
    23.9
    23.8
    16.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 36 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.
    End point type
    Secondary
    End point timeframe
    Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1592
    1578
    1507
    Units: Percentage of Participants
        number (not applicable)
    23.1
    22.7
    16.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 48 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.
    End point type
    Secondary
    End point timeframe
    Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    876
    860
    786
    Units: Percentage of Participants
        number (not applicable)
    24.9
    22.7
    18.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Month 60 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.
    End point type
    Secondary
    End point timeframe
    Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    526
    529
    478
    Units: Percentage of Participants
        number (not applicable)
    18.6
    20.0
    16.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Week 18 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 18.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2544
    2520
    2727
    Units: Percentage of Participants
        number (not applicable)
    9.0
    8.8
    4.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Week 52 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2363
    2347
    2311
    Units: Percentage of Participants
        number (not applicable)
    9.4
    10.9
    6.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 24 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 24.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1570
    1541
    1496
    Units: Percentage of Participants
        number (not applicable)
    9.2
    8.6
    5.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 36 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 36.
    End point type
    Secondary
    End point timeframe
    Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1592
    1578
    1507
    Units: Percentage of Participants
        number (not applicable)
    7.9
    8.0
    5.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 48 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 48.
    End point type
    Secondary
    End point timeframe
    Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    876
    860
    786
    Units: Percentage of Participants
        number (not applicable)
    8.1
    9.1
    7.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants with an A1C <6.5% (<48 mmol/mol) at Month 60 (Overall Cardiovascular Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all randomized and treated participants with an A1C measurement for the analysis endpoint for the specified timepoint(s) at Month 60.
    End point type
    Secondary
    End point timeframe
    Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    526
    529
    478
    Units: Percentage of Participants
        number (not applicable)
    5.3
    9.5
    6.5
    No statistical analyses for this end point

    Secondary: Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Time to the First Occurrence of a Participant Receiving Glycemic Rescue Therapy Through Week 18 (Overall Cardiovascular Study)
    End point description
    Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and received glycemic rescue by Week 18.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    141
    102
    275
    Units: Days
        median (inter-quartile range (Q1-Q3))
    59.0 (36 to 99)
    51.0 (18 to 91)
    74.0 (37 to 97)
    Statistical analysis title
    		 Superiority Log-Rank Test
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    416
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [47]
    Method
    		 Logrank
    Confidence interval
    Notes
    [47] - Based on the Log-Rank Test for the comparison to Placebo. Log-rank was based on all data including participants who never had the event.
    Statistical analysis title
    		 Superiority Log-Rank Test
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    377
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [48]
    Method
    		 Logrank
    Confidence interval
    Notes
    [48] - Based on the Log-Rank Test for the comparison to Placebo. Log-rank was based on all data including participants who never had the event.

    Secondary: Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Time to Initiation of Insulin for Participants Not on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    Participants who were not on insulin therapy at the start of study medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and were not on insulin therapy at the start of study medication.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1442
    1499
    1400
    Units: Days
        median (full range (min-max))
    602 (8 to 1850)
    650 (16 to 1934)
    482 (10 to 1838)
    Statistical analysis title
    		 Superiority Log-Rank Test
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    2842
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [49]
    Method
    		 Logrank
    Confidence interval
    Notes
    [49] - Log-Rank Test for the comparison to Placebo was based on all data (including participants who never had the event).
    Statistical analysis title
    		 Superiority Log-Rank Test
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    2899
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [50]
    Method
    		 Logrank
    Confidence interval
    Notes
    [50] - Log-Rank Test for the comparison to Placebo was based on all data (including participants who never had the event).

    Secondary: Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Baseline Insulin Dose for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    Baseline reflects Week 0 insulin dose. The analysis population included all participants who were randomized and were treated with insulin at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1304
    1248
    1345
    Units: Units/Day
        arithmetic mean (standard deviation)
    63.82 ( 48.11 )
    62.15 ( 44.46 )
    65.74 ( 46.34 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Insulin Dose at Week 18 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1297
    1237
    1304
    Units: Units/Day
        arithmetic mean (confidence interval 95%)
    1.05 (0.29 to 1.82)
    0.81 (-0.10 to 1.71)
    3.71 (2.70 to 4.70)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Insulin Dose at Week 52 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 52 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1103
    1067
    1130
    Units: Units/Day
        arithmetic mean (confidence interval 95%)
    0.84 (-0.15 to 1.82)
    -1.69 (-2.83 to -0.54)
    5.57 (4.16 to 6.98)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Insulin Dose at Month 24 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 24 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1004
    966
    998
    Units: Units/Day
        arithmetic mean (confidence interval 95%)
    0.45 (-0.72 to 1.63)
    -1.58 (-2.95 to -0.21)
    6.16 (4.47 to 7.85)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Insulin Dose at Month 36 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 36 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    465
    464
    419
    Units: Units/Day
        arithmetic mean (confidence interval 95%)
    1.64 (-0.77 to 4.05)
    -1.92 (-4.31 to 0.46)
    7.99 (4.65 to 11.34)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Insulin Dose at Month 48 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 48 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    387
    384
    326
    Units: Units/Day
        arithmetic mean (confidence interval 95%)
    2.96 (0.41 to 5.51)
    -1.87 (-4.80 to 1.05)
    7.28 (3.66 to 10.91)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Insulin Dose at Month 60 for Participants Who Were on Insulin at Baseline (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 60 insulin dose minus the Week 0 insulin dose. A negative number indicates a reduction in the insulin dose. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, were treated with insulin at Baseline, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    45
    47
    38
    Units: Units/Day
        arithmetic mean (confidence interval 95%)
    -2.47 (-9.65 to 4.72)
    -1.77 (-11.95 to 8.42)
    9.42 (1.46 to 17.39)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2745
    2747
    2744
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -32.18 (-33.76 to -30.61)
    -34.64 (-36.21 to -33.08)
    -17.08 (-18.69 to -15.48)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5489
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [51]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -15.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.03
         upper limit
    		 -13.17
    Notes
    [51] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [52]
    Method
    		 CLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -17.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.49
         upper limit
    		 -15.63
    Notes
    [52] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Week 52 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2352
    2328
    2295
    Units: mg/dL
        arithmetic mean (confidence interval 95%)
    -28.63 (-30.52 to -26.74)
    -28.97 (-30.78 to -27.15)
    -8.76 (-10.75 to -6.77)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Month 24 (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Month 24 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1562
    1536
    1487
    Units: mg/dL
        arithmetic mean (confidence interval 95%)
    -22.09 (-24.39 to -19.80)
    -24.31 (-26.76 to -21.86)
    -4.39 (-6.99 to -1.78)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Month 36 (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Month 36 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1579
    1567
    1491
    Units: mg/dL
        arithmetic mean (confidence interval 95%)
    -19.39 (-21.88 to -16.89)
    -22.59 (-24.96 to -20.21)
    -3.63 (-6.45 to -0.81)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Month 48 (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Month 48 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    868
    861
    777
    Units: mg/dL
        arithmetic mean (confidence interval 95%)
    -15.28 (-18.66 to -11.90)
    -16.16 (-19.50 to -12.83)
    3.59 (-0.22 to 7.40)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Month 60 (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Month 60 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    520
    524
    473
    Units: mg/dL
        arithmetic mean (confidence interval 95%)
    -13.87 (-18.34 to -9.40)
    -11.15 (-15.78 to -6.52)
    -4.69 (-9.72 to 0.34)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) at Month 72 (Overall Cardiovascular Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Month 72 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both baseline and Month 72.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    13
    12
    9
    Units: mg/dL
        arithmetic mean (confidence interval 95%)
    -2.46 (-31.28 to 26.36)
    -84.83 (-127.31 to -42.35)
    14.56 (-23.11 to 52.22)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2746
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -2.51 (-3.00 to -2.02)
    -2.75 (-3.24 to -2.26)
    0.03 (-0.48 to 0.53)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [53]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.21
         upper limit
    		 -1.86
    Notes
    [53] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [54]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.45
         upper limit
    		 -2.1
    Notes
    [54] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 52 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 52 sitting SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -1.84 (-2.35 to -1.32)
    -2.41 (-2.92 to -1.89)
    0.75 (0.23 to 1.26)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [55]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.28
         upper limit
    		 -1.89
    Notes
    [55] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [56]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Mean
    Point estimate
    -3.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.85
         upper limit
    		 -2.45
    Notes
    [56] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 24 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 24 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -1.80 (-2.42 to -1.19)
    -1.82 (-2.44 to -1.19)
    0.90 (0.27 to 1.53)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [57]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.56
         upper limit
    		 -1.85
    Notes
    [57] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [58]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.57
         upper limit
    		 -1.86
    Notes
    [58] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 36 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 36 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1593
    1580
    1505
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1.55 (-2.15 to -0.95)
    -1.21 (-1.84 to -0.59)
    0.84 (0.21 to 1.46)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 48 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 48 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -2.07 (-2.84 to -1.31)
    -2.26 (-3.03 to -1.49)
    0.53 (-0.27 to 1.33)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [59]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.68
         upper limit
    		 -1.52
    Notes
    [59] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [60]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.87
         upper limit
    		 -1.71
    Notes
    [60] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 60 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 60 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    525
    529
    479
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -2.18 (-3.29 to -1.08)
    -1.87 (-2.95 to -0.80)
    0.62 (-0.57 to 1.81)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Month 72 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 72 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    13
    12
    9
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    1.28 (-7.63 to 10.20)
    -3.46 (-10.91 to 3.99)
    2.72 (-5.95 to 11.40)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding rescue", excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2746
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -0.99 (-1.29 to -0.70)
    -1.08 (-1.38 to -0.79)
    -0.12 (-0.42 to 0.18)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [61]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Means Squares
    Point estimate
    -0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.28
         upper limit
    		 -0.47
    Notes
    [61] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [62]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.37
         upper limit
    		 -0.56
    Notes
    [62] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 52 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 52 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -0.97 (-1.28 to -0.67)
    -0.95 (-1.26 to -0.65)
    -0.15 (-0.45 to 0.16)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [63]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 -0.41
    Notes
    [63] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [64]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.22
         upper limit
    		 -0.39
    Notes
    [64] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 24 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 24 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: mmHg
        least squares mean (confidence interval 95%)
    -0.94 (-1.31 to -0.57)
    -0.90 (-1.27 to -0.53)
    -0.23 (-0.60 to 0.15)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [65]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.22
         upper limit
    		 -0.2
    Notes
    [65] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01 [66]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 -0.16
    Notes
    [66] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 36 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 36 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1.27 (-1.64 to -0.90)
    -0.92 (-1.29 to -0.55)
    -0.22 (-0.61 to 0.17)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 48 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 48 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -1.56 (-2.06 to -1.06)
    -1.23 (-1.74 to -0.73)
    -0.72 (-1.26 to -0.17)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 60 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 60 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    525
    529
    479
    Units: mmHg
        arithmetic mean (standard deviation)
    -1.82 ( 8.66 )
    -1.43 ( 9.36 )
    -1.26 ( 9.38 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)

    		 Close Top of page
    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Month 72 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 72 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2752
    2747
    2747
    Units: mmHg
        arithmetic mean (confidence interval 95%)
    -2.18 (-7.76 to 3.29)
    1.86 (-2.73 to 6.45)
    7.29 (1.63 to 12.94)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2746
    2745
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -2.03 (-2.14 to -1.92)
    -2.32 (-2.43 to -2.22)
    -0.40 (-0.51 to -0.30)
    Statistical analysis title
    		 Superiority cLDA Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [67]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.78
         upper limit
    		 -1.47
    Notes
    [67] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [68]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.07
         upper limit
    		 -1.77
    Notes
    [68] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Body Weight at Week 52 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 52 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2746
    2745
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -2.46 (-2.61 to -2.31)
    -2.84 (-2.99 to -2.69)
    -0.39 (-0.54 to -0.24)
    Statistical analysis title
    		 Ertu 15 mg vs placebo
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [69]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.67
         upper limit
    		 -2.24
    Notes
    [69] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [70]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.28
         upper limit
    		 -1.86
    Notes
    [70] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Body Weight at Month 24 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 24 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2746
    2745
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -2.75 (-2.95 to -2.56)
    -3.17 (-3.39 to -2.95)
    -0.65 (-0.85 to -0.44)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [71]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.39
         upper limit
    		 -1.83
    Notes
    [71] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [72]
    P-value
    		 < 0.001 [73]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.83
         upper limit
    		 -2.22
    Notes
    [72] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    [73] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Body Weight at Month 36 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 36 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and have at least one measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1595
    1578
    1506
    Units: Kilograms
        arithmetic mean (confidence interval 95%)
    -3.03 (-3.24 to -2.82)
    -3.41 (-3.63 to -3.20)
    -0.98 (-1.20 to -0.77)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Body Weight at Month 48 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 48 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after baseline).
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2746
    2745
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -3.39 (-3.69 to -3.10)
    -3.83 (-4.14 to -3.51)
    -1.29 (-1.59 to -1.00)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [74]
    P-value
    		 < 0.001 [75]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.52
         upper limit
    		 -1.68
    Notes
    [74] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    [75] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [76]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.97
         upper limit
    		 -2.1
    Notes
    [76] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Body Weight at Month 60 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 60 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    526
    530
    478
    Units: Kilograms
        arithmetic mean (confidence interval 95%)
    -3.66 (-4.11 to -3.20)
    -4.58 (-5.06 to -4.11)
    -1.21 (-1.63 to -0.78)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Body Weight at Month 72 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 72 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    13
    12
    9
    Units: Kilograms
        arithmetic mean (confidence interval 95%)
    -4.18 (-7.83 to -0.53)
    -7.37 (-12.67 to -2.07)
    -0.98 (-4.13 to 2.18)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 18 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 18 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint for the specified timepoint(s) a Baseline measurement and at least one assessment at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2671
    2667
    2661
    Units: mL/min/1.73 m^2
        least squares mean (confidence interval 95%)
    -1.22 (-1.66 to -0.77)
    -1.81 (-2.26 to -1.36)
    -0.03 (-0.48 to 0.42)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5332
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.82
         upper limit
    		 -0.56
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5328
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the Lease Squares Means
    Point estimate
    -1.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.41
         upper limit
    		 -1.15

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 52 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint for the specified timepoint(s) a Baseline measurement and at least one measurement at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2671
    2669
    2664
    Units: mL/min/1.73 m^2
        least squares mean (confidence interval 95%)
    -0.51 (-1.01 to -0.02)
    -1.18 (-1.67 to -0.68)
    -0.30 (-0.80 to 0.20)
    Statistical analysis title
    		 Superiority cLDA Model Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5335
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.91
         upper limit
    		 0.49
    Statistical analysis title
    		 Superiority cDLA Model Analysis
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5333
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the Lease Squares Means
    Point estimate
    -0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.58
         upper limit
    		 -0.18

    Secondary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 24 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 24 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1576
    1547
    1509
    Units: mL/min./1.73 m^2
        arithmetic mean (confidence interval 95%)
    -1.48 (-2.07 to -0.90)
    -2.35 (-2.94 to -1.76)
    -2.60 (-3.20 to -2.01)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    3056
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the least squares means
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.59
         upper limit
    		 1.08
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Constrained longitudinal data analysis (cLDA) model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    3085
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the least squares means
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.28
         upper limit
    		 1.95

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 36 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 36 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1591
    1577
    1504
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    -2.4 ( 14.0 )
    -2.3 ( 13.4 )
    -3.8 ( 14.1 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 48 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 48 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had for the analysis endpoint a Baseline measurement and at least 1 assessment after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2671
    2669
    2665
    Units: mL/min/1.73 m^2
        least squares mean (confidence interval 95%)
    -2.75 (-3.56 to -1.94)
    -2.93 (-3.73 to -2.13)
    -4.41 (-5.27 to -3.55)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5336
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 2.84
    Statistical analysis title
    		 superiority cLDA Model
    Statistical analysis description
    Based on cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5334
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in the Lease Squares Means
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 2.66

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 60 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 60 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    520
    529
    477
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    -2.4 ( 15.4 )
    -2.9 ( 14.1 )
    -6.8 ( 14.3 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Month 72 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 72 eGFR minus the Week 0 eGFR. A negative number indicates a reduction in the eGFR level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and time point.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    12
    12
    9
    Units: mL/min/1.73 m^2
        arithmetic mean (standard deviation)
    3.7 ( 12.9 )
    0.2 ( 12.2 )
    -1.8 ( 14.1 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Week 18 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 18 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2540
    2520
    2524
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.022 ( 0.154 )
    0.032 ( 0.148 )
    -0.002 ( 0.138 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Week 52 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Week 52 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received open-label glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2360
    2344
    2314
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.013 ( 0.166 )
    0.023 ( 0.163 )
    0.004 ( 0.156 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Month 24 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 24 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1574
    1548
    1506
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.024 ( 0.176 )
    0.035 ( 0.187 )
    0.034 ( 0.197 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Month 36 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 36 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1589
    1575
    1499
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.037 ( 0.194 )
    0.035 ( 0.188 )
    0.049 ( 0.194 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Month 48 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 48 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    875
    865
    787
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.032 ( 0.206 )
    0.036 ( 0.196 )
    0.059 ( 0.210 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Month 60 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 60 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    518
    528
    476
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.027 ( 0.202 )
    0.042 ( 0.216 )
    0.098 ( 0.248 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)

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    End point title
    		 Change from Baseline in Serum Creatinine at Month 72 (Overall Cardiovascular Study)
    End point description
    This change from baseline reflects the Month 72 serum creatinine minus the Week 0 serum creatinine. Participants who met glycemic rescue criteria received glycemic rescue medication. A negative number indicates a reduction in serum creatinine level. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 72.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 72
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    12
    12
    9
    Units: mg/dL
        arithmetic mean (standard deviation)
    -0.034 ( 0.176 )
    0.001 ( 0.120 )
    -0.013 ( 0.162 )
    No statistical analyses for this end point

    Secondary: Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)

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    End point title
    		 Baseline Urinary Albumin/Creatinine Ratio (Overall Cardiovascular Study)
    End point description
    Baseline reflects Week 0 albumin/creatinine ratio. The analysis population included all participants who were randomized and have for the analysis endpoint a baseline measurement.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2686
    2660
    2684
    Units: mg/g
        median (inter-quartile range (Q1-Q3))
    18.00 (6.00 to 68.00)
    19.00 (6.00 to 69.00)
    19.00 (6.00 to 66.50)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 18 (Overall Cardiovascular Study)
    End point description
    This percent change relative to baseline reflects the Week 18 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio divided by the baseline to obtain the percent. A negative number indicates a reduction in the urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2472
    2450
    2478
    Units: Percent Change
        median (inter-quartile range (Q1-Q3))
    -13.40 (-53.52 to 50.00)
    -14.71 (-55.53 to 50.00)
    0.00 (-44.44 to 66.67)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Week 52 (Overall Cardiovascular Study)
    End point description
    This percent change relative to baseline reflects the Week 52 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio divided by the baseline to obtain the percent. A negative number indicates a reduction in the albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Week 52.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2306
    2277
    2257
    Units: Percent Change
        median (inter-quartile range (Q1-Q3))
    -2.53 (-50.00 to 66.67)
    -6.82 (-50.00 to 66.67)
    5.41 (-40.00 to 96.34)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 24 (Overall Cardiovascular Study)
    End point description
    This percent change relative to baseline reflects the Month 24 urinary albumin/creatinine ratio minus the Week 0 urinary albumin/creatinine ratio divided by the Baseline to obtain the percent. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 24.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2125
    2084
    2025
    Units: Percent Change
        median (inter-quartile range (Q1-Q3))
    -0.73 (-48.96 to 100.00)
    1.06 (-47.78 to 95.26)
    17.14 (-38.00 to 140.00)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 36 (Overall Cardiovascular Study)
    End point description
    This percent change relative to baseline reflects the Month 36 urinary albumin/creatinine ratio minus the Week 0 urinary albumin/creatinine ratio divided by the baseline to obtain the percent. A negative number indicates a reduction in urinary albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1933
    1915
    1841
    Units: Percent Change
        median (inter-quartile range (Q1-Q3))
    13.33 (-49.34 to 120.37)
    3.33 (-49.44 to 100.00)
    27.03 (-38.46 to 177.78)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 48 (Overall Cardiovascular Study)
    End point description
    This percent change relative to baseline reflects the Month 48 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio divided by the baseline to obtain the percent. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 48.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    825
    835
    745
    Units: Percent change
        median (inter-quartile range (Q1-Q3))
    33.33 (-36.84 to 200.00)
    21.25 (-42.86 to 150.00)
    50.00 (-33.33 to 227.27)
    No statistical analyses for this end point

    Secondary: Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Percent Change from Baseline in Urinary Albumin/Creatinine Ratio at Month 60 (Overall Cardiovascular Study)
    End point description
    This percent change relative to baseline reflects the Month 60 albumin/creatinine ratio minus the Week 0 albumin/creatinine ratio divided by the baseline to obtain the percent. A negative number indicates a reduction in albumin/creatinine ratio. Participants who met glycemic rescue criteria received glycemic rescue medication. The analysis population included all participants who were randomized, received at least one dose of blinded study medication, and had a measurement for the analysis endpoint for the specified timepoint(s) at both Baseline and Month 60.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    780
    771
    692
    Units: Percent change
        median (inter-quartile range (Q1-Q3))
    30.99 (-40.00 to 200.00)
    20.00 (-45.83 to 150.00)
    48.53 (-28.57 to 222.41)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants With Albuminuria Progression or Regression at Week 18 (Overall Cardiovascular Study)
    End point description
    Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g). The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Week 18.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2472
    2450
    2478
    Units: Percentage of Participants
    number (not applicable)
        Participants with albuminuria progression
    7.6
    7.7
    10.8
        Participants with albuminuria regression
    14.9
    14.7
    10.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants With Albuminuria Progression or Regression at Week 52 (Overall Cardiovascular Study)
    End point description
    Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g). The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Week 52.
    End point type
    Secondary
    End point timeframe
    Week 52
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2306
    2277
    2257
    Units: Percentage of Participants
    number (not applicable)
        Participants with albuminuria progression
    9.5
    10.2
    12.9
        Participants with albuminuria regression
    14.6
    14.8
    10.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants With Albuminuria Progression or Regression at Month 24 (Overall Cardiovascular Study)
    End point description
    Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g). The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 24.
    End point type
    Secondary
    End point timeframe
    Month 24
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2125
    2084
    2025
    Units: Percentage of Participants
    number (not applicable)
        Participants with albuminuria progression
    12.1
    11.0
    16.9
        Participants with albuminuria regression
    14.3
    13.8
    9.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants With Albuminuria Progression or Regression at Month 36 (Overall Cardiovascular Study)
    End point description
    Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g). The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 36.
    End point type
    Secondary
    End point timeframe
    Month 36
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    1933
    1915
    1841
    Units: Percentage of Participants
    number (not applicable)
        Participants with albuminuria progression
    14.6
    12.5
    18.1
        Participants with albuminuria regression
    13.8
    14.3
    11.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants With Albuminuria Progression or Regression at Month 48 (Overall Cardiovascular Study)
    End point description
    Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g). The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 48.
    End point type
    Secondary
    End point timeframe
    Month 48
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    825
    835
    745
    Units: Percentage of Participants
    number (not applicable)
        Participants with albuminuria progression
    19.5
    14.9
    21.5
        Participants with albuminuria regression
    11.6
    12.2
    9.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants With Albuminuria Progression or Regression at Month 60 (Overall Cardiovascular Study)
    End point description
    Progression was defined as either a change from having normal-albuminuria at baseline to micro-albuminuria at the respective visit, or micro-albuminuria at baseline to macro-albuminuria at the respective visit, or normal albuminuria at baseline to macro-albuminuria at the respective visit. Regression was defined as either a change from having micro-albuminuria at baseline to normal albuminuria at the respective visit, or macro-albuminuria at baseline to micro-albuminuria at the respective visit, or macro-albuminuria at baseline to normal albuminuria at the respective visit. Normal albuminuria: urine albumin to urinary creatinine ratio (UACR) <30 (mg/g); Micro-albuminuria: UACR ≥30 and ≤300 (mg/g); Macro-albuminuria: UACR>300 (mg/g). The analysis population included all participants who were randomized, received at least one dose of blinded study medication, had a baseline measurement, and at least one measurement for the analysis endpoint for the specified timepoint at Month 60.
    End point type
    Secondary
    End point timeframe
    Month 60
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    780
    771
    692
    Units: Percentage of Participant
    number (not applicable)
        Participants with albuminuria progression
    18.6
    14.7
    22.1
        Participants with albuminuria regression
    11.3
    14.8
    10.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants Experiencing an Adverse Event (AE) (Overall Cardiovascular Study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: Percentage of Participants
        number (not applicable)
    85.8
    84.6
    85.6
    Statistical analysis title
    		 Superiority Miettinen & Nurminen method
    Comparison groups
    Ertugliflozin 5 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5491
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [77]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 2.1
    Notes
    [77] - Miettinen & Nurminen method
    Statistical analysis title
    		 Superiority Miettinen & Nurminen method
    Comparison groups
    Ertugliflozin 15 mg (Overall Cardiovascular Study) v Placebo (Overall Cardiovascular Study)
    Number of subjects included in analysis
    5492
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [78]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    -0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 0.9
    Notes
    [78] - Miettinen & Nurminen method

    Secondary: Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Percentage of Participants Experiencing an Adverse Event (AE) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: Percentage of Participant
        number (not applicable)
    59.2
    62.4
    61.1
    Statistical analysis title
    		 Superiority Miettinen & Nurminen method
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [79]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.2
         upper limit
    		 5.4
    Notes
    [79] - Miettinen & Nurminen method
    Statistical analysis title
    		 Superiority Miettinen & Nurminen method
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [80]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.8
         upper limit
    		 8.4
    Notes
    [80] - Miettinen & Nurminen method

    Secondary: Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Percentage of Participants Experiencing an Adverse Event (AE) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: Percentage of Participants
        number (not applicable)
    47.3
    25.9
    45.8
    Statistical analysis title
    		 Superiority Miettinen and Nurminen method
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [81]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -17.7
         upper limit
    		 20.4
    Notes
    [81] - Miettinen and Nurminen method
    Statistical analysis title
    		 Superiority Miettinen and Nurminen method
    Comparison groups
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [82]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    -19.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -37.5
         upper limit
    		 -1.2
    Notes
    [82] - Miettinen and Nurminen method

    Secondary: Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Percentage of Participants Experiencing an Adverse Event (AE) (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: Percentage of Participants
        number (not applicable)
    48.0
    54.9
    47.0
    Statistical analysis title
    		 Superiority Miettinen and Nurminen method
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [83]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.3
         upper limit
    		 14.2
    Notes
    [83] - Miettinen and Nurminen method
    Statistical analysis title
    		 Superiority Miettinen and Nurminen method
    Statistical analysis description
    Miettinen and Nurminen method
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.1
         upper limit
    		 20.5

    Secondary: Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)

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    End point title
    		 Percentage of Participants Discontinuing Study Treatment Due to An AE (Overall Cardiovascular Study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to approximately 6 years
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study)
    Number of subjects analysed
    2746
    2747
    2745
    Units: Percentage of Participants
        number (not applicable)
    7.5
    7.3
    6.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Percentage of Participants Discontinuing Study Treatment Due to An AE (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: Percentage of Participants
        number (not applicable)
    2.9
    3.8
    3.7
    Statistical analysis title
    		 Superiority Miettinen & Nurminen method
    Statistical analysis description
    Miettinen & Nurminen method
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [84]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 3
    Notes
    [84] - Miettinen & Nurminen method
    Statistical analysis title
    		 Superiority Miettinen & Nurminen method
    Statistical analysis description
    Miettinen & Nurminen method
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [85]
    Method
    Parameter type
    		 Difference in % vs Placebo
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 1.6
    Notes
    [85] - Miettinen & Nurminen method

    Secondary: Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Percentage of Participants Discontinuing Study Treatment Due to An AE (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: Percentage of Participants
        number (not applicable)
    3.6
    1.9
    2.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Percentage of Participants Discontinuing Study Treatment Due to An AE (Metformin With Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, and who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 18 weeks
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: Percentage of Participants
        number (not applicable)
    0
    2.7
    1.7
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in the FPG. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -26.98 (-32.80 to -21.17)
    -33.15 (-38.81 to -27.48)
    -7.74 (-13.67 to -1.81)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [86]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -19.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.8
         upper limit
    		 -11.68
    Notes
    [86] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [87]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -25.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -32.84
         upper limit
    		 -17.96
    Notes
    [87] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.

    Secondary: Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -1.87 (-2.22 to -1.52)
    -2.13 (-2.47 to -1.79)
    -0.25 (-0.60 to 0.11)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [88]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.12
         upper limit
    		 -1.13
    Notes
    [88] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [89]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.37
         upper limit
    		 -1.13
    Notes
    [89] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin) and the interaction of time by treatment.

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: Percentage of Participants
        number (not applicable)
    20.7
    21.1
    10.7
    Statistical analysis title
    		 Superiority cLDA Model
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [90]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted Odds Ratio Relative to Placebo
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.64
         upper limit
    		 4.12
    Notes
    [90] - Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model fitted with fixed effects for treatment, stratum for insulin sub-study, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted Odds Ratio Relative to Placebo
    Point estimate
    2.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.61
         upper limit
    		 3.83

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP level. Participants who met glycemic rescue criteria received open-label sitagliptin glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: mmHg
        least squares mean (confidence interval 95%)
    -2.67 (-4.17 to -1.18)
    -2.12 (-3.57 to -0.67)
    0.20 (-1.33 to 1.74)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [91]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.94
         upper limit
    		 -0.82
    Notes
    [91] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.025 [92]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -2.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.35
         upper limit
    		 -0.3
    Notes
    [92] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 DBP minus the Week 0 BBP. A negative number indicates a reduction in DBP level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication, and had at least one measurement for the analysis endpoint for the specified timepoint(s) at or after Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: mmHg
        least squares mean (confidence interval 95%)
    -0.86 (-1.72 to -0.00)
    -0.64 (-1.47 to 0.20)
    -0.26 (-1.14 to 0.62)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    695
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [93]
    P-value
    		 = 0.326
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.81
         upper limit
    		 0.6
    Notes
    [93] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) v Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects included in analysis
    717
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.533 [94]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.56
         upper limit
    		 0.81
    Notes
    [94] - Model with fixed effects for treatment, time, baseline eGFR, stratum (insulin alone or insulin + metformin), and the interaction of time by treatment.

    Secondary: Baseline Insulin Dose for Participants Receiving Insulin at Baseline (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Baseline Insulin Dose for Participants Receiving Insulin at Baseline (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    Baseline reflects Week 0 insulin dose. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, and received insulin at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    348
    370
    347
    Units: Unit/day
        arithmetic mean (standard deviation)
    70.76 ( 44.15 )
    67.29 ( 41.23 )
    73.20 ( 49.58 )
    No statistical analyses for this end point

    Secondary: Change from Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline at Week 18 in Insulin Dose for Participants Receiving Insulin at Baseline - Including Rescue Approach (Insulin With or Without Metformin Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 insulin dose minus the Week 0 insulin dose. A negative number indicates a decrease in insulin dose. Participants who met glycemic rescue criteria received glycemic rescue medication. "Including rescue", included data following the initiation of rescue therapy. The analysis population included all participants who were randomized, participated in the Insulin +/- Metformin Glycemic Sub-study, received at least one dose of study medication and had measurements of the analysis endpoint for the specified timepoint(s) both at Baseline and Week 18, and received insulin at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Insulin +/- Metformin Glycemic Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Sub-study)
    Number of subjects analysed
    347
    366
    346
    Units: Unit/day
        arithmetic mean (standard deviation)
    -0.71 ( 10.14 )
    -2.14 ( 10.23 )
    -0.29 ( 11.49 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -28.28 (-39.44 to -17.12)
    -26.97 (-38.51 to -15.44)
    -14.76 (-26.43 to -3.08)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.068 [95]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -13.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -28.06
         upper limit
    		 1
    Notes
    [95] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Comparison groups
    Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) v Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.105 [96]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -12.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -27.03
         upper limit
    		 2.06
    Notes
    [96] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.

    Secondary: Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -1.75 (-2.61 to -0.89)
    -1.20 (-2.09 to -0.31)
    -0.68 (-1.60 to 0.25)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.092 [97]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.32
         upper limit
    		 0.18
    Notes
    [97] - Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.418 [98]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.79
         upper limit
    		 0.75
    Notes
    [98] - Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: Percentage of Participants
        number (not applicable)
    32.7
    27.8
    25.0
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis.
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.335 [99]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio relative to placebo
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 4.35
    Notes
    [99] - Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis
    Comparison groups
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.46 [100]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio relative to placebo
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 4.17
    Notes
    [100] - Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the Constrained Longitudinal Data Analysis (cLDA) model fitted with fixed effects as in the primary analysis

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: mmHg
        least squares mean (confidence interval 95%)
    -0.72 (-4.06 to 2.63)
    -0.80 (-4.23 to 2.63)
    -3.53 (-7.03 to -0.02)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.235 [101]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.85
         upper limit
    		 7.48
    Notes
    [101] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.255 [102]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    2.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 7.45
    Notes
    [102] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Sulfonylurea Monotherapy Add-on Glycemic Sub-Study)
    End point description
    This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Sulfonylurea Monotherapy Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects analysed
    55
    54
    48
    Units: mmHg
        least squares mean (confidence interval 95%)
    -1.18 (-3.24 to 0.88)
    -0.93 (-3.05 to 1.18)
    -2.91 (-5.06 to -0.76)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.23 [103]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    1.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.11
         upper limit
    		 4.58
    Notes
    [103] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.
    Comparison groups
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) v Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.178 [104]
    Method
    		 cLDA model
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    1.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.91
         upper limit
    		 4.86
    Notes
    [104] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable.

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    FPG was analyzed after an overnight fast. This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. A negative number indicates a reduction in FPG level. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -35.28 (-43.05 to -27.50)
    -36.18 (-43.36 to -28.99)
    -4.81 (-12.10 to 2.49)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -30.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.23
         upper limit
    		 -20.72
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [105]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -31.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.68
         upper limit
    		 -22.07
    Notes
    [105] - cLDA model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.

    Secondary: Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Body Weight at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 body weight minus the Week 0 body weight. A negative number indicates a reduction in body weight. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: Kilograms
        least squares mean (confidence interval 95%)
    -2.04 (-2.58 to -1.50)
    -2.41 (-2.91 to -1.91)
    -0.47 (-0.97 to 0.03)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.3
         upper limit
    		 -0.84
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [106]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.65
         upper limit
    		 -1.24
    Notes
    [106] - Model with fixed effects for treatment, time, baseline eGFR (continuous), and the interaction of time by treatment.

    Secondary: Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Percentage of Participants with an A1C <7% (<53 mmol/mol) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    A1C is a blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). A1C represents the percentage of glycated hemoglobin. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Week 18
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: Percentage of Participants
        number (not applicable)
    37.0
    32.7
    12.8
    Statistical analysis title
    		 Superiority Logistic Regression Model
    Statistical analysis description
    Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [107]
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted odds ratio relative to placebo
    Point estimate
    5.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.86
         upper limit
    		 12.49
    Notes
    [107] - Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.
    Statistical analysis title
    		 Superiority Logistic Regression Model
    Statistical analysis description
    Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [108]
    Method
    		 Regression, Logistic
    Parameter type
    		 Adjusted odds ratio relative to placebo
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 8.42
    Notes
    [108] - Model fitted with fixed effects for treatment, covariates for baseline A1C and baseline eGFR (continuous). Missing data imputed using the cLDA model fitted with fixed effects as in the primary analysis.

    Secondary: Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Sitting Systolic Blood Pressure (SBP) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 SBP minus the Week 0 SBP. A negative number indicates a reduction in SBP. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: mmHg
        least squares mean (confidence interval 95%)
    -2.26 (-4.78 to 0.25)
    -1.54 (-3.85 to 0.77)
    -0.70 (-3.04 to 1.64)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.351 [109]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.87
         upper limit
    		 1.73
    Notes
    [109] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.597 [110]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 2.3
    Notes
    [110] - The model had fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)

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    End point title
    		 Change from Baseline in Sitting Diastolic Blood Pressure (DBP) at Week 18 (Excluding Rescue Approach) (Metformin with Sulfonylurea Add-on Glycemic Sub-study)
    End point description
    This change from baseline reflects the Week 18 DBP minus the Week 0 DBP. A negative number indicates a reduction in DBP. Participants who met glycemic rescue criteria received glycemic rescue medication. Participants who met glycemic rescue criteria received glycemic rescue medication. "Excluding Rescue" excluded all data following the initiation of rescue in order to avoid the confounding influence of the rescue therapy. The analysis population included all participants who were randomized, participated in the Metformin with Sulfonylurea Glycemic Sub-study, received at least one dose of study medication and had at least one measurement of the analysis endpoint for the specified timepoint(s) at any time from Baseline to Week 18.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects analysed
    100
    113
    117
    Units: mmHg
        least squares mean (confidence interval 95%)
    -0.30 (-1.80 to 1.21)
    -0.92 (-2.30 to 0.46)
    -0.24 (-1.64 to 1.15)
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.958 [111]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.07
         upper limit
    		 1.96
    Notes
    [111] - Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Statistical analysis title
    		 Superiority cLDA Model
    Statistical analysis description
    Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.
    Comparison groups
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) v Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.49 [112]
    Method
    		 cLDA
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 1.25
    Notes
    [112] - Model with fixed effects for treatment, time, baseline eGFR (continuous) and the interaction of time by treatment.

    Secondary: Baseline Serum Creatinine (Overall Cardiovascular Study)

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    End point title
    		 Baseline Serum Creatinine (Overall Cardiovascular Study)
    End point description
    Baseline reflects Week 0 serum creatinine. The analysis population included all participants who were randomized, and had a measurement for the analysis endpoint for the specified timepoint at Baseline.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Ertugliflozin 5 mg (Overall Cardiovascular Study) Ertugliflozin 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) All Ertugliflozin (Overall Cardiovascular Study)
    Number of subjects analysed
    2739
    2740
    2736
    5479
    Units: mg/dL
        arithmetic mean (standard deviation)
    0.992 ( 0.278 )
    0.985 ( 0.277 )
    0.991 ( 0.281 )
    0.998 ( 0.278 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall Cardiovascular study - Up to approximately 6 years; 3 Glycemic Sub-studies - Up to 18 weeks
    Adverse event reporting additional description
    The analysis population for all-cause mortality was all randomized participants and the analysis population for adverse events was all participants who received at least one dose of blinded study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Ertu 5 mg (Overall Cardiovascular Study)
    Reporting group description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Ertu 15 mg (Overall Cardiovascular Study)
    Reporting group description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Placebo (Overall Cardiovascular Study)
    Reporting group description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years

    Reporting group title
    Ertu 5 mg (Insulin +/- Metformin Sub-study)
    Reporting group description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Reporting group title
    Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study)
    Reporting group description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Reporting group title
    Placebo (Insulin +/- Metformin Glycemic Sub-study)
    Reporting group description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Reporting group title
    Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Reporting group description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Reporting group title
    Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Reporting group description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Reporting group title
    Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study)
    Reporting group description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Reporting group title
    Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study)
    Reporting group description
    		 Ertugliflozin 5 mg, administered orally, once daily, for up to 18 weeks

    Reporting group title
    Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study)
    Reporting group description
    		 Ertugliflozin 15 mg, administered orally, once daily, for up to 18 weeks

    Reporting group title
    Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Reporting group description
    		 Matching placebo to ertugliflozin administered orally, once daily, for up to 18 weeks

    Serious adverse events
    		 Ertu 5 mg (Overall Cardiovascular Study) Ertu 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) Ertu 5 mg (Insulin +/- Metformin Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Glycemic Sub-study) Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    958 / 2746 (34.89%)
    937 / 2747 (34.11%)
    990 / 2745 (36.07%)
    33 / 348 (9.48%)
    27 / 370 (7.30%)
    37 / 347 (10.66%)
    4 / 55 (7.27%)
    1 / 54 (1.85%)
    2 / 48 (4.17%)
    7 / 100 (7.00%)
    8 / 113 (7.08%)
    6 / 117 (5.13%)
         number of deaths (all causes)
    228
    233
    247
    4
    6
    1
    0
    1
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute promyelocytic leukaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 2746 (0.04%)
    4 / 2747 (0.15%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical fibroxanthoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    20 / 2746 (0.73%)
    25 / 2747 (0.91%)
    16 / 2745 (0.58%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 30
    0 / 21
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basosquamous carcinoma of skin
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    5 / 2746 (0.18%)
    4 / 2747 (0.15%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma stage II
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone giant cell tumour malignant
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm benign
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoma in situ of skin
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac myxoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell endometrial carcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    4 / 2746 (0.15%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma stage IV
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer stage III
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric neoplasm
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hair follicle tumour benign
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    High-grade B-cell lymphoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal papillary-mucinous carcinoma of pancreas
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large cell lung cancer
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leiomyosarcoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma stage 0
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    5 / 2746 (0.18%)
    3 / 2747 (0.11%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphocytic leukaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Marginal zone lymphoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesothelioma malignant
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to abdominal cavity
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to spine
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic lymphoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm of orbit
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour of the lung metastatic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oral neoplasm
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    3 / 2746 (0.11%)
    3 / 2747 (0.11%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    1 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma recurrent
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranasal sinus benign neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranasal sinus neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penis carcinoma metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    16 / 2746 (0.58%)
    10 / 2747 (0.36%)
    11 / 2745 (0.40%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 10
    0 / 11
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    3 / 2746 (0.11%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage I
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    3 / 2747 (0.11%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine carcinoma metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    7 / 2746 (0.25%)
    8 / 2747 (0.29%)
    10 / 2745 (0.36%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 12
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    5 / 2746 (0.18%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular cancer metastatic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue cancer recurrent
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue neoplasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tumour of ampulla of Vater
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulval cancer stage I
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Pulmonary oedema
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accelerated hypertension
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    7 / 2746 (0.25%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brachiocephalic artery stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    6 / 2747 (0.22%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 8
    1 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic vasculitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 2746 (0.07%)
    5 / 2747 (0.18%)
    11 / 2745 (0.40%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 12
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    4 / 2746 (0.15%)
    0 / 2747 (0.00%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    10 / 2745 (0.36%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    1 / 10
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iliac artery rupture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    5 / 2746 (0.18%)
    3 / 2747 (0.11%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 3
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    16 / 2746 (0.58%)
    20 / 2747 (0.73%)
    22 / 2745 (0.80%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 23
    0 / 25
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    3 / 2746 (0.11%)
    3 / 2747 (0.11%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 9
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    5 / 2747 (0.18%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    3 / 2746 (0.11%)
    2 / 2747 (0.07%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    17 / 2746 (0.62%)
    13 / 2747 (0.47%)
    10 / 2745 (0.36%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 18
    0 / 10
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    4 / 2746 (0.15%)
    3 / 2747 (0.11%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery occlusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Atrial appendage closure
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site phlebitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    17 / 2746 (0.62%)
    8 / 2747 (0.29%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 9
    0 / 8
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    35 / 2746 (1.27%)
    22 / 2747 (0.80%)
    25 / 2745 (0.91%)
    3 / 348 (0.86%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 22
    0 / 25
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 35
    0 / 22
    0 / 25
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hanging
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    4 / 2746 (0.15%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    26 / 2746 (0.95%)
    16 / 2747 (0.58%)
    22 / 2745 (0.80%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 18
    0 / 23
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Physical deconditioning
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    4 / 2746 (0.15%)
    3 / 2747 (0.11%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulcer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acquired phimosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    10 / 2746 (0.36%)
    12 / 2747 (0.44%)
    7 / 2745 (0.26%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis noninfective
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic dysplasia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular mass
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    8 / 2746 (0.29%)
    7 / 2747 (0.25%)
    9 / 2745 (0.33%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
    0 / 9
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    3 / 2746 (0.11%)
    2 / 2747 (0.07%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    11 / 2746 (0.40%)
    6 / 2747 (0.22%)
    14 / 2745 (0.51%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 10
    0 / 19
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 2746 (0.00%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract inflammation
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    11 / 2746 (0.40%)
    4 / 2747 (0.15%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary granuloma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    9 / 2746 (0.33%)
    6 / 2747 (0.22%)
    11 / 2745 (0.40%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
    0 / 11
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mood disorder due to a general medical condition
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device stimulation issue
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis chronic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 2746 (0.07%)
    7 / 2747 (0.25%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    2 / 370 (0.54%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 6
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    11 / 2746 (0.40%)
    4 / 2747 (0.15%)
    11 / 2745 (0.40%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
    0 / 11
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    5 / 2746 (0.18%)
    9 / 2747 (0.33%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder necrosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis cholestatic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post cholecystectomy syndrome
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Antipsychotic drug level increased
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    3 / 2746 (0.11%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 3
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin T increased
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    3 / 2746 (0.11%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial bypass occlusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial bypass stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial bypass thrombosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous graft site stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac contusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusion postoperative
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary vascular graft occlusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear canal injury
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiphyseal fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 2746 (0.11%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    6 / 2746 (0.22%)
    2 / 2747 (0.07%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body in respiratory tract
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heat exhaustion
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    4 / 2746 (0.15%)
    3 / 2747 (0.11%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury corneal
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    4 / 2746 (0.15%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Median nerve injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve root injury cervical
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoradionecrosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paranasal sinus injury
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprocedural myocardial infarction
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural discharge
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative respiratory failure
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postpericardiotomy syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural nausea
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    2 / 2746 (0.07%)
    5 / 2747 (0.18%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    5 / 2747 (0.18%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    4 / 2746 (0.15%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    4 / 2746 (0.15%)
    6 / 2747 (0.22%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic lung injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular access site haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    6 / 2746 (0.22%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    9 / 2746 (0.33%)
    6 / 2747 (0.22%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
    0 / 8
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    52 / 2746 (1.89%)
    76 / 2747 (2.77%)
    73 / 2745 (2.66%)
    3 / 348 (0.86%)
    1 / 370 (0.27%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 61
    1 / 83
    0 / 80
    0 / 3
    1 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    1 / 7
    0 / 6
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adams-Stokes syndrome
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    38 / 2746 (1.38%)
    42 / 2747 (1.53%)
    49 / 2745 (1.79%)
    2 / 348 (0.57%)
    2 / 370 (0.54%)
    3 / 347 (0.86%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 39
    0 / 48
    1 / 54
    1 / 2
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    74 / 2746 (2.69%)
    71 / 2747 (2.58%)
    89 / 2745 (3.24%)
    3 / 348 (0.86%)
    1 / 370 (0.27%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    1 / 48 (2.08%)
    0 / 100 (0.00%)
    2 / 113 (1.77%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 92
    0 / 78
    2 / 106
    0 / 3
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anginal equivalent
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    3 / 2746 (0.11%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    30 / 2746 (1.09%)
    31 / 2747 (1.13%)
    37 / 2745 (1.35%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 38
    1 / 40
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    11 / 2746 (0.40%)
    9 / 2747 (0.33%)
    9 / 2745 (0.33%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
    0 / 11
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 2746 (0.11%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    5 / 2746 (0.18%)
    5 / 2747 (0.18%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 2746 (0.04%)
    5 / 2747 (0.18%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block right
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    7 / 2746 (0.25%)
    15 / 2747 (0.55%)
    13 / 2745 (0.47%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 15
    0 / 13
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    0 / 9
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac asthma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    35 / 2746 (1.27%)
    34 / 2747 (1.24%)
    43 / 2745 (1.57%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 36
    0 / 58
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    7 / 2746 (0.25%)
    7 / 2747 (0.25%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 11
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    16 / 2746 (0.58%)
    10 / 2747 (0.36%)
    14 / 2745 (0.51%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 12
    0 / 17
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    19 / 2746 (0.69%)
    28 / 2747 (1.02%)
    35 / 2745 (1.28%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 37
    1 / 42
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    4 / 2746 (0.15%)
    5 / 2747 (0.18%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    3 / 2746 (0.11%)
    4 / 2747 (0.15%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 8
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    35 / 2746 (1.27%)
    34 / 2747 (1.24%)
    38 / 2745 (1.38%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 43
    1 / 36
    1 / 42
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    2 / 2746 (0.07%)
    5 / 2747 (0.18%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    14 / 2746 (0.51%)
    20 / 2747 (0.73%)
    16 / 2745 (0.58%)
    0 / 348 (0.00%)
    2 / 370 (0.54%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 22
    0 / 18
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary ostial stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive cardiomyopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    4 / 2747 (0.15%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microvascular coronary artery disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    39 / 2746 (1.42%)
    49 / 2747 (1.78%)
    37 / 2745 (1.35%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 52
    0 / 41
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    17 / 2746 (0.62%)
    13 / 2747 (0.47%)
    18 / 2745 (0.66%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 14
    0 / 21
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postinfarction angina
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    4 / 2746 (0.15%)
    3 / 2747 (0.11%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachyarrhythmia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systolic dysfunction
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular failure
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    3 / 2746 (0.11%)
    5 / 2747 (0.18%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    2 / 2746 (0.07%)
    13 / 2747 (0.47%)
    7 / 2745 (0.26%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 13
    0 / 8
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain hypoxia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    4 / 2746 (0.15%)
    4 / 2747 (0.15%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem stroke
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    11 / 2746 (0.40%)
    13 / 2747 (0.47%)
    12 / 2745 (0.44%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
    0 / 14
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral circulatory failure
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    6 / 2746 (0.22%)
    13 / 2747 (0.47%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    27 / 2746 (0.98%)
    25 / 2747 (0.91%)
    22 / 2745 (0.80%)
    2 / 348 (0.57%)
    3 / 370 (0.81%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 27
    1 / 30
    1 / 23
    0 / 2
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    5 / 2746 (0.18%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    1 / 55 (1.82%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 2746 (0.00%)
    3 / 2747 (0.11%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparaesthesia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersomnia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    29 / 2746 (1.06%)
    40 / 2747 (1.46%)
    41 / 2745 (1.49%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    1 / 54 (1.85%)
    1 / 48 (2.08%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 40
    0 / 45
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukoencephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mixed dementia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Motor dysfunction
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelitis transverse
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgic amyotrophy
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral paralysis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    1 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reversible ischaemic neurological deficit
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    8 / 2746 (0.29%)
    10 / 2747 (0.36%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 10
    1 / 9
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    19 / 2746 (0.69%)
    14 / 2747 (0.51%)
    23 / 2745 (0.84%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 14
    0 / 25
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    5 / 2746 (0.18%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic thrombocytopenic purpura
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deafness neurosensory
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Middle ear inflammation
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    4 / 2746 (0.15%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    8 / 2746 (0.29%)
    13 / 2747 (0.47%)
    17 / 2745 (0.62%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 17
    0 / 22
    0 / 0
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinal oedema
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery embolism
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal disorder
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tractional retinal detachment
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreoretinal traction syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous adhesions
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    5 / 2746 (0.18%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anogenital dysplasia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Buccal polyp
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 2746 (0.00%)
    5 / 2747 (0.18%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    3 / 2746 (0.11%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erosive duodenitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    4 / 2746 (0.15%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    6 / 2746 (0.22%)
    6 / 2747 (0.22%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 6
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    4 / 2746 (0.15%)
    5 / 2747 (0.18%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal mass
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 4
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric panniculitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic duct dilatation
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    6 / 2746 (0.22%)
    7 / 2747 (0.25%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis haemorrhagic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctitis haemorrhagic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 2746 (0.04%)
    7 / 2747 (0.25%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 2746 (0.07%)
    6 / 2747 (0.22%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    10 / 2746 (0.36%)
    9 / 2747 (0.33%)
    13 / 2745 (0.47%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
    0 / 14
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic skin ulcer
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lichen sclerosus
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    5 / 2746 (0.18%)
    7 / 2747 (0.25%)
    4 / 2745 (0.15%)
    2 / 348 (0.57%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    24 / 2746 (0.87%)
    18 / 2747 (0.66%)
    22 / 2745 (0.80%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    3 / 24
    3 / 18
    7 / 24
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder dysplasia
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder outlet obstruction
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder tamponade
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    6 / 2747 (0.22%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 7
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 2746 (0.15%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stag horn calculus
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal haematoma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal mass
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenocortical insufficiency acute
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 2746 (0.15%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 2746 (0.04%)
    4 / 2747 (0.15%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    4 / 2746 (0.15%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone cyst
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Connective tissue inflammation
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint contracture
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loose body in joint
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle fatigue
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    10 / 2746 (0.36%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteitis deformans
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    22 / 2746 (0.80%)
    16 / 2747 (0.58%)
    21 / 2745 (0.77%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 18
    0 / 23
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    4 / 2746 (0.15%)
    3 / 2747 (0.11%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    6 / 2746 (0.22%)
    3 / 2747 (0.11%)
    3 / 2745 (0.11%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Undifferentiated connective tissue disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    3 / 2746 (0.11%)
    5 / 2747 (0.18%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess of salivary gland
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Actinomycosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebic colitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    3 / 2747 (0.11%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerotic gangrene
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspergilloma
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 2746 (0.18%)
    6 / 2747 (0.22%)
    11 / 2745 (0.40%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 11
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    21 / 2746 (0.76%)
    31 / 2747 (1.13%)
    21 / 2745 (0.77%)
    0 / 348 (0.00%)
    3 / 370 (0.81%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 33
    0 / 26
    0 / 0
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endotoxic shock
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    16 / 2746 (0.58%)
    16 / 2747 (0.58%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    2 / 370 (0.54%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 20
    0 / 8
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gas gangrene
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 2746 (0.18%)
    4 / 2747 (0.15%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective thrombosis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    4 / 2746 (0.15%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymph node tuberculosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningoencephalitis bacterial
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    14 / 2746 (0.51%)
    10 / 2747 (0.36%)
    6 / 2745 (0.22%)
    2 / 348 (0.57%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 11
    0 / 8
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraspinal abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perihepatic abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    51 / 2746 (1.86%)
    46 / 2747 (1.67%)
    45 / 2745 (1.64%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 58
    0 / 48
    0 / 49
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    3 / 2746 (0.11%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    1 / 117 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 2746 (0.11%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    22 / 2746 (0.80%)
    12 / 2747 (0.44%)
    7 / 2745 (0.26%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 12
    0 / 7
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic embolus
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic encephalopathy
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 2746 (0.07%)
    8 / 2747 (0.29%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 8
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tropical ulcer
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    1 / 370 (0.27%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis of eye
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    2 / 2745 (0.07%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    16 / 2746 (0.58%)
    10 / 2747 (0.36%)
    14 / 2745 (0.51%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    9 / 24
    5 / 10
    5 / 15
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 2746 (0.07%)
    1 / 2747 (0.04%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    2 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cardiometabolic syndrome
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 2746 (0.07%)
    3 / 2747 (0.11%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    5 / 2746 (0.18%)
    1 / 2747 (0.04%)
    6 / 2745 (0.22%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 6
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    12 / 2746 (0.44%)
    6 / 2747 (0.22%)
    14 / 2745 (0.51%)
    1 / 348 (0.29%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    1 / 113 (0.88%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
    1 / 14
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    4 / 2746 (0.15%)
    5 / 2747 (0.18%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 5
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    4 / 2746 (0.15%)
    4 / 2747 (0.15%)
    5 / 2745 (0.18%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 5
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    4 / 2745 (0.15%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    0 / 2746 (0.00%)
    1 / 2747 (0.04%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 2746 (0.11%)
    4 / 2747 (0.15%)
    8 / 2745 (0.29%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 8
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 2746 (0.07%)
    4 / 2747 (0.15%)
    3 / 2745 (0.11%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperosmolar state
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 2746 (0.00%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    12 / 2746 (0.44%)
    9 / 2747 (0.33%)
    14 / 2745 (0.51%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    7 / 17
    2 / 9
    2 / 14
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    2 / 2746 (0.07%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insulin-requiring type 2 diabetes mellitus
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    2 / 2746 (0.07%)
    2 / 2747 (0.07%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ketosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 2746 (0.04%)
    0 / 2747 (0.00%)
    1 / 2745 (0.04%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 2746 (0.04%)
    1 / 2747 (0.04%)
    0 / 2745 (0.00%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 2746 (0.00%)
    2 / 2747 (0.07%)
    2 / 2745 (0.07%)
    0 / 348 (0.00%)
    0 / 370 (0.00%)
    0 / 347 (0.00%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    0 / 100 (0.00%)
    0 / 113 (0.00%)
    0 / 117 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ertu 5 mg (Overall Cardiovascular Study) Ertu 15 mg (Overall Cardiovascular Study) Placebo (Overall Cardiovascular Study) Ertu 5 mg (Insulin +/- Metformin Sub-study) Ertu 15 mg (Insulin +/- Metformin Glycemic Sub-study) Placebo (Insulin +/- Metformin Glycemic Sub-study) Ertu 5 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 15 mg (Sulfonylurea Monotherapy Glycemic Sub-Study) Placebo (Sulfonylurea Monotherapy Glycemic Sub-Study) Ertu 5 mg (Metformin with Sulfonylurea Glycemic Sub-study) Ertu 15 mg (Metformin with Sulfonylurea Glycemic Sub-study) Placebo (Metformin with Sulfonylurea Glycemic Sub-study)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1405 / 2746 (51.17%)
    1389 / 2747 (50.56%)
    1395 / 2745 (50.82%)
    101 / 348 (29.02%)
    112 / 370 (30.27%)
    109 / 347 (31.41%)
    3 / 55 (5.45%)
    3 / 54 (5.56%)
    0 / 48 (0.00%)
    13 / 100 (13.00%)
    19 / 113 (16.81%)
    14 / 117 (11.97%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    133 / 2746 (4.84%)
    148 / 2747 (5.39%)
    168 / 2745 (6.12%)
    5 / 348 (1.44%)
    4 / 370 (1.08%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    4 / 100 (4.00%)
    2 / 113 (1.77%)
    3 / 117 (2.56%)
         occurrences all number
    218
    272
    343
    5
    4
    2
    0
    0
    0
    4
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    139 / 2746 (5.06%)
    141 / 2747 (5.13%)
    89 / 2745 (3.24%)
    8 / 348 (2.30%)
    9 / 370 (2.43%)
    4 / 347 (1.15%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    2 / 100 (2.00%)
    4 / 113 (3.54%)
    1 / 117 (0.85%)
         occurrences all number
    174
    179
    107
    8
    10
    4
    0
    0
    0
    2
    4
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    132 / 2746 (4.81%)
    138 / 2747 (5.02%)
    126 / 2745 (4.59%)
    7 / 348 (2.01%)
    9 / 370 (2.43%)
    8 / 347 (2.31%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    2 / 100 (2.00%)
    3 / 113 (2.65%)
    0 / 117 (0.00%)
         occurrences all number
    163
    161
    153
    7
    11
    8
    0
    0
    0
    2
    3
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    133 / 2746 (4.84%)
    138 / 2747 (5.02%)
    143 / 2745 (5.21%)
    2 / 348 (0.57%)
    2 / 370 (0.54%)
    2 / 347 (0.58%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    1 / 113 (0.88%)
    2 / 117 (1.71%)
         occurrences all number
    144
    157
    160
    2
    2
    2
    0
    0
    0
    1
    1
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    178 / 2746 (6.48%)
    204 / 2747 (7.43%)
    186 / 2745 (6.78%)
    4 / 348 (1.15%)
    13 / 370 (3.51%)
    11 / 347 (3.17%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    2 / 100 (2.00%)
    5 / 113 (4.42%)
    3 / 117 (2.56%)
         occurrences all number
    249
    272
    244
    4
    13
    12
    0
    0
    0
    2
    5
    3
    Upper respiratory tract infection
         subjects affected / exposed
    197 / 2746 (7.17%)
    177 / 2747 (6.44%)
    203 / 2745 (7.40%)
    8 / 348 (2.30%)
    10 / 370 (2.70%)
    9 / 347 (2.59%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    3 / 100 (3.00%)
    2 / 113 (1.77%)
    4 / 117 (3.42%)
         occurrences all number
    277
    257
    324
    8
    11
    9
    0
    0
    0
    3
    2
    4
    Urinary tract infection
         subjects affected / exposed
    256 / 2746 (9.32%)
    262 / 2747 (9.54%)
    211 / 2745 (7.69%)
    8 / 348 (2.30%)
    9 / 370 (2.43%)
    7 / 347 (2.02%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    1 / 100 (1.00%)
    4 / 113 (3.54%)
    3 / 117 (2.56%)
         occurrences all number
    378
    354
    301
    8
    10
    7
    0
    0
    0
    1
    5
    4
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    106 / 2746 (3.86%)
    96 / 2747 (3.49%)
    178 / 2745 (6.48%)
    1 / 348 (0.29%)
    1 / 370 (0.27%)
    1 / 347 (0.29%)
    0 / 55 (0.00%)
    0 / 54 (0.00%)
    0 / 48 (0.00%)
    3 / 100 (3.00%)
    2 / 113 (1.77%)
    1 / 117 (0.85%)
         occurrences all number
    158
    201
    283
    1
    1
    1
    0
    0
    0
    3
    2
    1
    Hypoglycaemia
         subjects affected / exposed
    883 / 2746 (32.16%)
    854 / 2747 (31.09%)
    884 / 2745 (32.20%)
    101 / 348 (29.02%)
    112 / 370 (30.27%)
    109 / 347 (31.41%)
    3 / 55 (5.45%)
    3 / 54 (5.56%)
    0 / 48 (0.00%)
    13 / 100 (13.00%)
    19 / 113 (16.81%)
    14 / 117 (11.97%)
         occurrences all number
    10056
    9474
    11591
    400
    541
    559
    4
    3
    0
    23
    110
    49

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Mar 2016
    Amendment 1 - Added a superiority analysis on the newly-added secondary endpoints of cardiovascular death or hospitalization for heart failure (composite) and cardiovascular death (individual component). Changed the non-inferiority analysis plan: Stage 2 will be only based on the results of the current study and will not be a meta-analysis across Phase 2 and Phase 3. Increased the overall sample size to approximately 8000 participants. Added a glycemic sub-study in participants receiving metformin plus sulfonylurea (SU).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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