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    Clinical Trial Results:
    A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2009-012140-16
    Trial protocol
    		 GB   DE   ES   HU   EE   CZ   SE   BE  
    Global end of trial date
    22 Feb 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Mar 2018
    First version publication date
    10 Mar 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    28431754DIA3008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01032629
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen- Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry group, Janssen- Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen- Cilag International NV, ClinicalTrialsEU@its.jnj.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
    22 Feb 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess the effect of canagliflozin plus standard of care relative to placebo plus standard of care on cardiovascular (CV) risk as measured by the hazard ratio (HR) for a composite endpoint (major adverse cardiovascular events [MACE] including CV death, nonfatal myocardial infarction [MI], or nonfatal stroke) and to assess the safety and tolerability of canagliflozin plus standard of care relative to placebo plus standard of care. Furthermore, study DIA3008 together with study DIA4003, constitutes the CANVAS program. An integrated analysis of CANVAS for cardiovascular safety was to use all subjects in DIA3008 and DIA4003 to show that a canagliflozin-associated risk in the CV risk ratio (if any), was significantly less than 1.3 using the two-sided 95 percent (%) confidence interval of the risk ratio.
    Protection of trial subjects
    Safety was evaluated based on the following variables: adverse events, safety laboratory tests (hematology, serum chemistry, urinalysis), hypoglycemic episodes (as collected in a specific electronic case report forms [eCRF]), vital sign measurements (blood pressure and pulse rate), and 12-lead electrocardiograms (ECGs). Several monitoring and adjudication committees were commissioned for this study, including an Academic Research Organization (ARO) which provided scientific and academic oversight and site monitoring for some sites; a Steering Committee of external scientific experts; an Independent Data Monitoring Committee (IDMC); an independent Endpoint Adjudication Committee (EAC), which reviewed blinded data for selected specific events; separate adjudication committees, which were employed to review cases of diabetic ketoacidosis (DKA), fracture, renal events, and pancreatitis; and a company-internal Medical Safety Review Committee (MSRC).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Nov 2009
    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: 160
    Country: Number of subjects enrolled
    Australia: 177
    Country: Number of subjects enrolled
    Belgium: 21
    Country: Number of subjects enrolled
    Canada: 396
    Country: Number of subjects enrolled
    Colombia: 7
    Country: Number of subjects enrolled
    Czech Republic: 117
    Country: Number of subjects enrolled
    Germany: 175
    Country: Number of subjects enrolled
    Spain: 209
    Country: Number of subjects enrolled
    Estonia: 44
    Country: Number of subjects enrolled
    United Kingdom: 92
    Country: Number of subjects enrolled
    Hungary: 125
    Country: Number of subjects enrolled
    India: 695
    Country: Number of subjects enrolled
    Israel: 25
    Country: Number of subjects enrolled
    Luxembourg: 1
    Country: Number of subjects enrolled
    Mexico: 124
    Country: Number of subjects enrolled
    Malaysia: 73
    Country: Number of subjects enrolled
    Netherlands: 228
    Country: Number of subjects enrolled
    Norway: 109
    Country: Number of subjects enrolled
    New Zealand: 74
    Country: Number of subjects enrolled
    Poland: 144
    Country: Number of subjects enrolled
    Russian Federation: 389
    Country: Number of subjects enrolled
    Sweden: 71
    Country: Number of subjects enrolled
    Ukraine: 147
    Country: Number of subjects enrolled
    United States: 727
    Worldwide total number of subjects
    4330
    EEA total number of subjects
    1336
    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)
    2602
    From 65 to 84 years
    1723
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 7693 subjects screened, a total of 4,330 subjects were randomized, with 1,442, 1,445, and 1,443 subjects assigned to placebo, canagliflozin 100 milligram (mg) and canagliflozin 300 mg respectively.

    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, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.

    Arm title
    		 Canagliflozin 100 mg
    Arm description
    		 Subjects received one canagliflozin 100 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one canagliflozin 100 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Arm title
    		 Canagliflozin 300 mg
    Arm description
    		 Subjects received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Number of subjects in period 1
    		Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Started
    1442
    1445
    1443
    Completed
    1297
    1344
    1355
    Not completed
    145
    101
    88
         Consent withdrawn by subject
    50
    36
    35
         Other - closed site
    21
    18
    16
         Lost to follow-up
    74
    47
    37

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin 100 mg
    Reporting group description
    		 Subjects received one canagliflozin 100 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin 300 mg
    Reporting group description
    		 Subjects received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg Total
    Number of subjects
    		 1442 1445 1443 4330
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 890 874 838 2602
        From 65 to 84 years
    		 549 571 603 1723
        85 years and over
    		 3 0 2 5
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.3 ( 7.94 ) 62.2 ( 8 ) 62.8 ( 8.13 ) -
    Title for Gender
    Units: subjects
        Female
    		 486 484 499 1469
        Male
    		 956 961 944 2861

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin 100 mg
    Reporting group description
    		 Subjects received one canagliflozin 100 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin 300 mg
    Reporting group description
    		 Subjects received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Subject analysis set title
    Canagliflozin (Total)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received one canagliflozin 100 mg or 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Primary: Time to the First Occurrence of Major Adverse Cardiovascular Events (MACE), Including CV Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke

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    End point title
    		 Time to the First Occurrence of Major Adverse Cardiovascular Events (MACE), Including CV Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke
    End point description
    Time to the first occurrence of Major Adverse Cardiovascular Events (MACE), defined as a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. The primary analysis was based on the intent-to-treat (ITT) analysis set for adjudicated MACE, and included all randomized subjects. Event rate estimated based on the time to the first occurrence of MACE are presented.
    End point type
    Primary
    End point timeframe
    Up to approximately 8 years
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg Canagliflozin (Total)
    Number of subjects analysed
    1442
    1445
    1443
    2888
    Units: Events per 1000 patient-year
        number (not applicable)
    30.36
    28.41
    25.37
    26.89
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2887
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4576
    Method
    		 Cox proportional hazard model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.12
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0467
    Method
    		 Cox proportional hazard model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin (Total)
    Number of subjects included in analysis
    4330
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.112
    Method
    		 Cox proportional hazard method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.03

    Secondary: Change from Baseline in Homeostasis Model Assessment 2 Steady-state Beta-Cell Function (HOMA2-%B) at the end-of-Treatment (EOT)

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    End point title
    		 Change from Baseline in Homeostasis Model Assessment 2 Steady-state Beta-Cell Function (HOMA2-%B) at the end-of-Treatment (EOT)
    End point description
    The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and any post-baseline HOMA-B measurements, and didn’t receive insulin through baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    463
    511
    477
    Units: Beta cell function
        least squares mean (standard error)
    4.02 ( 1.611 )
    6.82 ( 1.533 )
    8.09 ( 1.587 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    974
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21
    Method
    		 ANCOVA
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    2.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.571
         upper limit
    		 7.154
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.224
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    940
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.072
    Method
    		 ANCOVA
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    4.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.368
         upper limit
    		 8.504
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.261

    Secondary: Percentage of Subjects With Progression of Albuminuria at the end-of-Treatment

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    End point title
    		 Percentage of Subjects With Progression of Albuminuria at the end-of-Treatment
    End point description
    Progression defined as the development of micro-albuminuria (ACR greater than or equal to [>=] 30 mg/g and smaller than or equal to <= 300 mg/g) or macroalbuminuria (ACR of >300 mg/g) in a subject with baseline normoalbuminuria or the development of macro-albuminuria in a subject with baseline microalbuminuria. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were treated, had both baseline and post−baseline ACR measurements, and baseline ACR<=300 mg/g.
    End point type
    Secondary
    End point timeframe
    End of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1286
    1334
    1298
    Units: Percentage of subjects
        number (not applicable)
    24.0
    20.2
    18.3
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2620
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.97
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2584
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.85

    Secondary: Change from Baseline in Proinsulin/Insulin Ratio at the end-of-Treatment

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    End point title
    		 Change from Baseline in Proinsulin/Insulin Ratio at the end-of-Treatment
    End point description
    A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and any post-baseline proinsulin/insulin ratio measurements, and didn’t receive insulin through baseline.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    370
    426
    412
    Units: Picomole per milli international units
        least squares mean (standard error)
    0.70 ( 0.150 )
    0.67 ( 0.140 )
    1.03 ( 0.142 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    796
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.429
         upper limit
    		 0.374
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.205
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    782
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.079
         upper limit
    		 0.731
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.206

    Secondary: Change From Baseline in Urinary Albumin/Creatinine Ratio at end-of-Treatment

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    End point title
    		 Change From Baseline in Urinary Albumin/Creatinine Ratio at end-of-Treatment
    End point description
    Urinary Albumin/Creatinine Ratio was reported at end of Treatment. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint and had both baseline and post-baseline ACR measurements.
    End point type
    Secondary
    End point timeframe
    End of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1377
    1398
    1384
    Units: Milligram per gram (mg/g)
        geometric mean (confidence interval 95%)
    29.30 (27.66 to 31.03)
    25.50 (24.09 to 27)
    24.47 (23.11 to 25.91)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2775
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.94
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2761
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.91

    Secondary: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at end-of-Treatment

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    End point title
    		 Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at end-of-Treatment
    End point description
    Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of Treatment. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and post-baseline eGFR measurements.
    End point type
    Secondary
    End point timeframe
    Baseline, end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1394
    1412
    1383
    Units: Milliliter/minute/1.73*square meter
        least squares mean (standard error)
    -5.23 ( 0.390 )
    -3.55 ( 0.388 )
    -3.98 ( 0.392 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2806
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.599
         upper limit
    		 2.755
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.55
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2777
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    1.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.16
         upper limit
    		 2.328
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.553

    Secondary: Change From Baseline in Glycated Hemoglobin (HbA1c) at end-of-Treatment

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    End point title
    		 Change From Baseline in Glycated Hemoglobin (HbA1c) at end-of-Treatment
    End point description
    Change from baseline in Glycated Hemoglobin (HbA1c) was assessed at end of Treatment. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and any post-baseline HbA1C measurements.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1366
    1392
    1352
    Units: Percentage of HbA1c
        least squares mean (standard error)
    0.01 ( 0.032 )
    -0.26 ( 0.032 )
    -0.31 ( 0.032 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2758
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -0.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.355
         upper limit
    		 -0.177
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.045
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2718
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.405
         upper limit
    		 -0.227
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.046

    Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) Levels at end-of-Treatment

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    End point title
    		 Change From Baseline in Fasting Plasma Glucose (FPG) Levels at end-of-Treatment
    End point description
    Change from baseline in the fasting plasma glucose was assessed. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint and had both baseline and post-baseline fasting plasma glucose measurements.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1392
    1410
    1377
    Units: Millimoles per liter (mmol/L)
        least squares mean (standard error)
    0.16 ( 0.076 )
    -0.42 ( 0.075 )
    -0.57 ( 0.076 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2802
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.794
         upper limit
    		 -0.374
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.107
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2769
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.945
         upper limit
    		 -0.523
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.108

    Secondary: Percent Change From Baseline in Body Weight at end-of-Treatment

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    End point title
    		 Percent Change From Baseline in Body Weight at end-of-Treatment
    End point description
    Percent change from baseline in body weight was assessed at the end of treatment. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and post-baseline body weight.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1398
    1415
    1388
    Units: Percent change
        least squares mean (standard error)
    -0.50 ( 0.184 )
    -3.47 ( 0.183 )
    -4.12 ( 0.185 )
    Statistical analysis title
    		 Statistical anaysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2813
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -2.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.472
         upper limit
    		 -2.454
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.26
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2786
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -3.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.125
         upper limit
    		 -3.103
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.261

    Secondary: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at end-of-Treatment

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    End point title
    		 Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at end-of-Treatment
    End point description
    Change from baseline in SBP and DBP were assessed. On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and post-baseline blood pressure measurements.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1398
    1415
    1388
    Units: Millimeter of mercury (mmHg)
    least squares mean (standard error)
        SBP(Change from baseline at end of treatment)
    -1.96 ( 0.377 )
    -4.91 ( 0.375 )
    -6.49 ( 0.378 )
        DBP (Change from baseline at end of treatment)
    -2.88 ( 0.223 )
    -3.70 ( 0.221 )
    -4.51 ( 0.223 )
    Statistical analysis title
    		 Statistical analysis 1 (Systolic blood pressure)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2813
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -2.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.998
         upper limit
    		 -1.914
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.532
    Statistical analysis title
    		 Statistical analysis 2 (Systolic blood pressure)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2786
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -4.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.579
         upper limit
    		 -3.484
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.534
    Statistical analysis title
    		 Statistical analysis 3 (Diastolic blood pressure)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2786
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.437
         upper limit
    		 -0.205
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.314
    Statistical analysis title
    		 Statistical analysis 4 (Diastolic blood pressure)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2786
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    -1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.245
         upper limit
    		 -1.007
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.316

    Secondary: Change From Baseline in Triglycerides Levels at end-of-Treatment

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    End point title
    		 Change From Baseline in Triglycerides Levels at end-of-Treatment
    End point description
    Change from baseline in triglycerides levels was assessed. On treatment set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1325
    1371
    1321
    Units: mmol/L
        arithmetic mean (standard deviation)
    0.05 ( 1.597 )
    0.13 ( 1.679 )
    0.09 ( 1.238 )
    Statistical analysis title
    		 Statistical analysis 1 (Triglycerides)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2696
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Wilcoxon rank sum test
    Parameter type
    		 Hodges-Lehman Estimate
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.07
    Statistical analysis title
    		 Statistical analysis 2 (Triglycerides)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2646
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    		 Wilcoxon rank sum test
    Parameter type
    		 Hodges-Lehman Estimate
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.03
         upper limit
    		 0.08

    Secondary: Change from Baseline in Cholesterol, HDL-C and LDL-C Levels at end-of-Treatment

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    End point title
    		 Change from Baseline in Cholesterol, HDL-C and LDL-C Levels at end-of-Treatment
    End point description
    Change from baseline in cholesterol, HDL-C and LDL-C Levels were assessed. On treatment set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and post-baseline lipid measurements.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1325
    1371
    1321
    Units: mmol/L
    least squares mean (standard error)
        Cholesterol (change from baseline at EOT)
    -0.07 ( 0.028 )
    0.11 ( 0.027 )
    0.16 ( 0.028 )
        HDL-C (change from baseline at EOT)
    -0.01 ( 0.006 )
    0.04 ( 0.006 )
    0.05 ( 0.006 )
        LDL-C (change from baseline at EOT)
    -0.07 ( 0.022 )
    0.04 ( 0.022 )
    0.10 ( 0.023 )
    Statistical analysis title
    		 Statistical analysis 1 (Cholesterol)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2696
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.105
         upper limit
    		 0.259
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.039
    Statistical analysis title
    		 Statistical analysis 2 (Cholesterol)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2646
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.152
         upper limit
    		 0.307
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.039
    Statistical analysis title
    		 Statistical analysis 3 (HDL-C)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2696
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.031
         upper limit
    		 0.065
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.009
    Statistical analysis title
    		 Statistical analysis 4 (HDL-C)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2646
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.04
         upper limit
    		 0.075
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.009
    Statistical analysis title
    		 Statistical analysis 5 (LDL-C)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2696
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.046
         upper limit
    		 0.17
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.032
    Statistical analysis title
    		 Statistical analysis 6 (LDL-C)
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2646
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.102
         upper limit
    		 0.226
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.032

    Secondary: Change from Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at end-of-Treatment

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    End point title
    		 Change from Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at end-of-Treatment
    End point description
    Change from baseline in LDL-C to HDL-C ratio was assessed. On treatment set included all randomized subjects who were treated and received at least 1 dose of study drug. Here 'N' signifies number of subjects who were evaluable for this endpoint who had both baseline and post-baseline lipid measurements.
    End point type
    Secondary
    End point timeframe
    Baseline and end of treatment (approximately maximum 338 weeks)
    End point values
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Number of subjects analysed
    1325
    1371
    1321
    Units: Ratio
        least squares mean (standard error)
    -0.04 ( 0.021 )
    -0.02 ( 0.021 )
    0.00 ( 0.021 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    2696
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.04
         upper limit
    		 0.076
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.03
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 300 mg
    Number of subjects included in analysis
    2646
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference of Least Square Mean
    Point estimate
    0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.023
         upper limit
    		 0.094
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.03

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 8 years
    Adverse event reporting additional description
    On-treatment analysis set included all randomized subjects who were treated and received at least 1 dose of study drug. The number of deaths (all causes) is adjudicated death that occurred within 30 days of the last dose of the study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received one placebo capsule orally once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin 100 mg
    Reporting group description
    		 Subjects received one canagliflozin 100 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Reporting group title
    Canagliflozin 300 mg
    Reporting group description
    		 Subjects received one canagliflozin 300 mg capsule once daily for the duration of the study or until early discontinuation from treatment.

    Serious adverse events
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    584 / 1441 (40.53%)
    601 / 1445 (41.59%)
    606 / 1441 (42.05%)
         number of deaths (all causes)
    74
    68
    66
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Leukaemia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Adenocarcinoma Gastric
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Adenocarcinoma of Colon
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenolymphoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenosquamous Cell Lung Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adrenal Adenoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendix Adenoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign Neoplasm of Bladder
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign Neoplasm of Prostate
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign Peritoneal Neoplasm
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile Duct Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    5 / 1441 (0.35%)
    4 / 1445 (0.28%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    Bladder Cancer Stage 0, with Cancer in Situ
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Papilloma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 3
    0 / 8
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
    Breast Cancer Recurrent
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer Stage I
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial Carcinoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Bronchial Neoplasm Benign
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carcinoid Tumour Pulmonary
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carcinoid Tumour of the Duodenum
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid Body Tumour
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondrosarcoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondrosarcoma Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Chronic Myeloid Leukaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Myelomonocytic Leukaemia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Clear Cell Renal Cell Carcinoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    4 / 1441 (0.28%)
    1 / 1445 (0.07%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Colon Cancer Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Colon Cancer Stage Iii
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial Adenocarcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gallbladder Cancer Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Tract Adenoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head and Neck Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Hepatic Cancer Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    3 / 1441 (0.21%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Kidney Angiomyolipoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large Cell Lung Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Large Intestine Benign Neoplasm
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lentigo Maligna
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Adenocarcinoma Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Cancer Metastatic
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Lung Neoplasm Malignant
         subjects affected / exposed
    4 / 1441 (0.28%)
    3 / 1445 (0.21%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    Lung Squamous Cell Carcinoma Stage 0
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocytic Lymphoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant Melanoma in Situ
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melanocytic Naevus
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to Bone
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastases to Central Nervous System
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastases to Lymph Nodes
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to Peritoneum
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Metastases to Small Intestine
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic Carcinoid Tumour
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic Carcinoma of the Bladder
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastatic Malignant Melanoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic Renal Cell Carcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Monoclonal Gammopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myeloid Leukaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Myeloproliferative Neoplasm
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine Carcinoma Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine Carcinoma of the Skin
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer Stage Iv
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Oesophageal Adenocarcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Ovarian Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Ovarian Cancer Metastatic
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    3 / 1441 (0.21%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    Pancreatic Neoplasm
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papillary Serous Endometrial Carcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papillary Thyroid Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraneoplastic Syndrome
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Parathyroid Tumour Benign
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    7 / 1441 (0.49%)
    8 / 1445 (0.55%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer Metastatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer Recurrent
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Prostatic Adenoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Rectal Adenoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal Cancer Recurrent
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectosigmoid Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Cancer Metastatic
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal Cancer Stage I
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal Cell Carcinoma Stage Ii
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Neoplasm
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Oncocytoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcoma Uterus
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seminoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of the Oral Cavity
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of the Tongue
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superficial Spreading Melanoma Stage Unspecified
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular Seminoma (Pure)
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Throat Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid Adenoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid Cancer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsil Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional Cell Cancer of the Renal Pelvis and Ureter
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional Cell Carcinoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine Cancer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulvovaginal Warts
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated Hypertension
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic Aneurysm
         subjects affected / exposed
    4 / 1441 (0.28%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic Stenosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Arterial Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial Occlusive Disease
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial Thrombosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Pressure Inadequately Controlled
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    3 / 1441 (0.21%)
    4 / 1445 (0.28%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Dry Gangrene
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    10 / 1441 (0.69%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    4 / 1441 (0.28%)
    5 / 1445 (0.35%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Emergency
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 1441 (0.21%)
    5 / 1445 (0.35%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iliac Artery Occlusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intermittent Claudication
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leriche Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant Hypertension
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurogenic Shock
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    4 / 1441 (0.28%)
    12 / 1445 (0.83%)
    11 / 1441 (0.76%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 19
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Aneurysm
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Occlusion
         subjects affected / exposed
    1 / 1441 (0.07%)
    7 / 1445 (0.48%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    4 / 1441 (0.28%)
    5 / 1445 (0.35%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    9 / 1441 (0.62%)
    9 / 1445 (0.62%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    7 / 1441 (0.49%)
    8 / 1445 (0.55%)
    10 / 1441 (0.69%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Subclavian Artery Stenosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose Vein
         subjects affected / exposed
    3 / 1441 (0.21%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Arrhythmia Prophylaxis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture Treatment
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Bypass
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip Arthroplasty
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional Hernia Repair
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse Drug Reaction
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Application Site Dermatitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    23 / 1441 (1.60%)
    26 / 1445 (1.80%)
    13 / 1441 (0.90%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 28
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complication Associated with Device
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    8 / 1441 (0.56%)
    8 / 1445 (0.55%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 8
    0 / 8
    0 / 8
    Drug Intolerance
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial Pain
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised Oedema
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired Healing
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical Device Site Reaction
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Necrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    2 / 1441 (0.14%)
    8 / 1445 (0.55%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perforated Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Swelling
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Strangulated Hernia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden Cardiac Death
         subjects affected / exposed
    5 / 1441 (0.35%)
    0 / 1445 (0.00%)
    9 / 1441 (0.62%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    0 / 9
    Sudden Death
         subjects affected / exposed
    6 / 1441 (0.42%)
    5 / 1445 (0.35%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 6
    0 / 5
    0 / 3
    Vascular Stent Occlusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Stent Restenosis
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Atopy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food Allergy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired Phimosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenomyosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 1441 (0.07%)
    8 / 1445 (0.55%)
    15 / 1441 (1.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical Dysplasia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial Hyperplasia
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epididymal Cyst
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erectile Dysfunction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genital Prolapse
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis Noninfective
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic Prolapse
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic Calcification
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterovaginal Prolapse
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal Prolapse
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    6 / 1441 (0.42%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    3 / 1441 (0.21%)
    4 / 1445 (0.28%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial Hyperreactivity
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    7 / 1441 (0.49%)
    7 / 1445 (0.48%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphonia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    8 / 1441 (0.56%)
    11 / 1445 (0.76%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dyspnoea Exertional
         subjects affected / exposed
    3 / 1441 (0.21%)
    4 / 1445 (0.28%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal Oedema
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Consolidation
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Infiltration
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal Polyps
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Organising Pneumonia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Productive Cough
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    7 / 1441 (0.49%)
    5 / 1445 (0.35%)
    9 / 1441 (0.62%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    1 / 9
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    Pulmonary Fibrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pulmonary Hypertension
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    3 / 1441 (0.21%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary Vein Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Acidosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Arrest
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    6 / 1441 (0.42%)
    3 / 1445 (0.21%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    Sinus Polyp
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    4 / 1441 (0.28%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Affective Disorder
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Confusional State
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium Tremens
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination, Visual
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    4 / 1441 (0.28%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizoaffective Disorder
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Cognitive Impairment
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device Breakage
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device Damage
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic Liver Disease
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile Duct Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 1441 (0.14%)
    5 / 1445 (0.35%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    4 / 1441 (0.28%)
    6 / 1445 (0.42%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    11 / 1441 (0.76%)
    9 / 1445 (0.62%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug-Induced Liver Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Pain
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Perforation
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Polyp
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hepatic Failure
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hepatic Fibrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Steatosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatomegaly
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatorenal Syndrome
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Jaundice Cholestatic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Alcoholic Steatohepatitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Portal Hypertension
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Portal Vein Thrombosis
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Cholecystectomy Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Glucose Abnormal
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Glucose Increased
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Pressure Abnormal
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Pressure Decreased
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood Pressure Increased
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Stress Test Abnormal
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheterisation Cardiac
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium Test Positive
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram Abnormal
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram St Segment Depression
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram St-T Segment Abnormal
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exercise Test Abnormal
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraocular Pressure Increased
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver Function Test Increased
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Precancerous Cells Present
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Function Test Abnormal
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Troponin Increased
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    3 / 1441 (0.21%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental Overdose
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acetabulum Fracture
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    3 / 1441 (0.21%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaesthetic Complication
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Animal Bite
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    6 / 1445 (0.42%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial Bypass Occlusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial Bypass Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone Contusion
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain Contusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Restenosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Dural Tear
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    4 / 1445 (0.28%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign Body
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign Body in Eye
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture Displacement
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Heat Stroke
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    3 / 1441 (0.21%)
    4 / 1445 (0.28%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    2 / 1441 (0.14%)
    4 / 1445 (0.28%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle Rupture
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral Artery Restenosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Concussion Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Bile Leak
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Complication
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Renal Failure
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Respiratory Failure
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Thoracic Procedure Complication
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Wound Complication
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural Nausea
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural Vomiting
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Skin Injury
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull Fractured Base
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Cord Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sternal Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomal Hernia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous Haematoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    4 / 1445 (0.28%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic Haematoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic Intracranial Haemorrhage
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Retention Postoperative
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Graft Complication
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound Complication
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound Necrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous Malformation
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Developmental Hip Dysplasia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitello-Intestinal Duct Remnant
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    8 / 1441 (0.56%)
    3 / 1445 (0.21%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Acute Left Ventricular Failure
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    10 / 1441 (0.69%)
    10 / 1445 (0.69%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
    Adams-Stokes Syndrome
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    24 / 1441 (1.67%)
    15 / 1445 (1.04%)
    30 / 1441 (2.08%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 16
    0 / 38
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Angina Unstable
         subjects affected / exposed
    20 / 1441 (1.39%)
    24 / 1445 (1.66%)
    28 / 1441 (1.94%)
         occurrences causally related to treatment / all
    1 / 24
    1 / 28
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anginal Equivalent
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic Valve Incompetence
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic Valve Stenosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    3 / 1441 (0.21%)
    0 / 1445 (0.00%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Atrial Fibrillation
         subjects affected / exposed
    26 / 1441 (1.80%)
    22 / 1445 (1.52%)
    17 / 1441 (1.18%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 28
    1 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    6 / 1441 (0.42%)
    6 / 1445 (0.42%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    4 / 1441 (0.28%)
    2 / 1445 (0.14%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    6 / 1441 (0.42%)
    7 / 1445 (0.48%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    0 / 5
    Cardiac Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    19 / 1441 (1.32%)
    19 / 1445 (1.31%)
    23 / 1441 (1.60%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 28
    1 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
    Cardiac Failure Acute
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    5 / 1441 (0.35%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    20 / 1441 (1.39%)
    15 / 1445 (1.04%)
    14 / 1441 (0.97%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 23
    0 / 15
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    0 / 3
    Cardio-Respiratory Arrest
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    1 / 3
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    Cardiomyopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary Failure
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular Disorder
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    24 / 1441 (1.67%)
    24 / 1445 (1.66%)
    23 / 1441 (1.60%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 28
    0 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Coronary Artery Insufficiency
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    5 / 1441 (0.35%)
    5 / 1445 (0.35%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Thrombosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Hypertensive Heart Disease
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left Ventricular Dysfunction
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial Fibrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    16 / 1441 (1.11%)
    18 / 1445 (1.25%)
    11 / 1441 (0.76%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 18
    0 / 11
         deaths causally related to treatment / all
    0 / 4
    0 / 11
    0 / 7
    Myocardial Ischaemia
         subjects affected / exposed
    9 / 1441 (0.62%)
    11 / 1445 (0.76%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 14
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Palpitations
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis Constrictive
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulseless Electrical Activity
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Restrictive Cardiomyopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Right Ventricular Failure
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    6 / 1441 (0.42%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular Arrhythmia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Ventricular Tachycardia
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Alcoholic Seizure
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic Lateral Sclerosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal Ganglia Infarction
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basilar Artery Occlusion
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain Injury
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain Stem Haemorrhage
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Brain Stem Infarction
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Carotid Arteriosclerosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    5 / 1441 (0.35%)
    5 / 1445 (0.35%)
    11 / 1441 (0.76%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid Sinus Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar Ataxia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar Infarction
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral Arteriosclerosis
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    10 / 1441 (0.69%)
    13 / 1445 (0.90%)
    13 / 1441 (0.90%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 6
    Cervicobrachial Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cubital Tunnel Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depressed Level of Consciousness
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Coma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Hyperosmolar Coma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial Paralysis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial Paresis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised Tonic-Clonic Seizure
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Headache
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Encephalopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic Coma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemic Encephalopathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intercostal Neuralgia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial Haematoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    4 / 1441 (0.28%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    Lacunar Infarction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lacunar Stroke
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral Radiculopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental Impairment
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Motor Dysfunction
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myasthenia Gravis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic Intolerance
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paralysis Recurrent Laryngeal Nerve
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinson's Disease
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Petit Mal Epilepsy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Herpetic Neuralgia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reversible Cerebral Vasoconstriction Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Serotonin Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Claudication
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    7 / 1441 (0.49%)
    9 / 1445 (0.62%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    15 / 1441 (1.04%)
    7 / 1445 (0.48%)
    16 / 1441 (1.11%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 8
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Encephalopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Vertigo CNS Origin
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal Cord Paralysis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 1441 (0.56%)
    2 / 1445 (0.14%)
    7 / 1441 (0.49%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypochromic Anaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microcytic Anaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pernicious Anaemia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness Neurosensory
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis Fugax
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blindness Unilateral
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    8 / 1441 (0.56%)
    8 / 1445 (0.55%)
    10 / 1441 (0.69%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract Diabetic
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract Nuclear
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract Subcapsular
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dacryostenosis Acquired
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Retinopathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exophthalmos
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye Haemorrhage
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid Ptosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lens Dislocation
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular Degeneration
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular Fibrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular Hole
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Maculopathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ocular Myasthenia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Open Angle Glaucoma
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Optic Ischaemic Neuropathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal Vascular Thrombosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinopathy Proliferative
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulcerative Keratitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual Impairment
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitreous Floaters
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitreous Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Incarcerated Hernia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    4 / 1441 (0.28%)
    3 / 1445 (0.21%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Wall Haematoma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal Fissure
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowel Movement Irregularity
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis Microscopic
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Dysplasia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic Pseudo-Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dieulafoy's Vascular Malformation
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    4 / 1441 (0.28%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erosive Duodenitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eructation
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallstone Ileus
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Mucosal Hypertrophy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Perforation
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric Ulcer Perforation
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Erosion
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Necrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernial Eventration
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus Hernia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated Umbilical Hernia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 1441 (0.00%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Ischaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal Polyp
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intra-Abdominal Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss Syndrome
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Achalasia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Varices Haemorrhage
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Cyst
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic Pseudocyst
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    1 / 1441 (0.07%)
    4 / 1445 (0.28%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Haemorrhagic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pancreatitis Necrotising
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    4 / 1441 (0.28%)
    6 / 1445 (0.42%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    3 / 1441 (0.21%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Varices Oesophageal
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decubitus Ulcer
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis Contact
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    4 / 1441 (0.28%)
    9 / 1445 (0.62%)
    10 / 1441 (0.69%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Neuropathic Ulcer
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Ulcer
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Eruption
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Guttate Psoriasis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity Vasculitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Keloid Scar
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lichen Planus
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrobiosis Lipoidica Diabeticorum
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurodermatitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Lesion
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    2 / 1441 (0.14%)
    10 / 1445 (0.69%)
    14 / 1441 (0.97%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 11
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    13 / 1441 (0.90%)
    15 / 1445 (1.04%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 16
    2 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Azotaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Bladder Neck Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Prolapse
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus Bladder
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis Haemorrhagic
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Nephropathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    7 / 1441 (0.49%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal Artery Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    1 / 1441 (0.07%)
    6 / 1445 (0.42%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 7
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Papillary Necrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Tubular Necrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress Urinary Incontinence
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Terminal Dribbling
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial Nephritis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral Meatus Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Bladder Polyp
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Empty Sella Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism Primary
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inappropriate Antidiuretic Hormone Secretion
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroiditis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Acquired Claw Toe
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankylosing Spondylitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    3 / 1441 (0.21%)
    5 / 1445 (0.35%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    3 / 1441 (0.21%)
    5 / 1445 (0.35%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone Atrophy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone Cyst
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondromalacia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Arthropathy
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's Contracture
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flank Pain
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gouty Arthritis
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gouty Tophus
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Compression
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Disorder
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    4 / 1441 (0.28%)
    3 / 1445 (0.21%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Juvenile Idiopathic Arthritis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    8 / 1445 (0.55%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lupus-Like Syndrome
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle Atrophy
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck Pain
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathic Arthropathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    27 / 1441 (1.87%)
    30 / 1445 (2.08%)
    23 / 1441 (1.60%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 39
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    4 / 1441 (0.28%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 1441 (0.00%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia Rheumatica
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriatic Arthropathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Senile Osteoporosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    6 / 1441 (0.42%)
    4 / 1445 (0.28%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    4 / 1441 (0.28%)
    3 / 1445 (0.21%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovial Cyst
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon Disorder
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral Foraminal Stenosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal Sepsis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    4 / 1441 (0.28%)
    5 / 1445 (0.35%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis Infective
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical Pneumonia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary Sepsis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    4 / 1441 (0.28%)
    5 / 1445 (0.35%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis Bacterial
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopulmonary Aspergillosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burn Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter Gastroenteritis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    19 / 1441 (1.32%)
    15 / 1445 (1.04%)
    15 / 1441 (1.04%)
         occurrences causally related to treatment / all
    1 / 19
    0 / 25
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cellulitis Gangrenous
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis Staphylococcal
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis Infective
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Hepatitis B
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon Gangrene
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Gangrene
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal Bacteraemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    5 / 1441 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye Infection Fungal
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    4 / 1441 (0.28%)
    15 / 1445 (1.04%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 17
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 1441 (0.42%)
    5 / 1445 (0.35%)
    8 / 1441 (0.56%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin Abscess
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiv Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Cyst
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Dermal Cyst
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    2 / 1441 (0.14%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective Exacerbation of Bronchiectasis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1441 (0.00%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Intervertebral Discitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    4 / 1445 (0.28%)
    10 / 1441 (0.69%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    7 / 1441 (0.49%)
    1 / 1445 (0.07%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical Device Site Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis Viral
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrotising Fasciitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nosocomial Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal Candidiasis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral Candidiasis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    7 / 1441 (0.49%)
    11 / 1445 (0.76%)
    12 / 1441 (0.83%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis Externa
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pathogen Resistance
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perineal Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perinephric Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasmodium Vivax Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    36 / 1441 (2.50%)
    31 / 1445 (2.15%)
    26 / 1441 (1.80%)
         occurrences causally related to treatment / all
    1 / 41
    0 / 35
    0 / 27
         deaths causally related to treatment / all
    0 / 2
    0 / 6
    0 / 2
    Pneumonia Bacterial
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia Influenzal
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Cellulitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    2 / 1445 (0.14%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    5 / 1441 (0.35%)
    2 / 1445 (0.14%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal Bacteraemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoas Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis Chronic
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal Tuberculosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    3 / 1441 (0.21%)
    2 / 1445 (0.14%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection Viral
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    10 / 1441 (0.69%)
    12 / 1445 (0.83%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
    Septic Shock
         subjects affected / exposed
    3 / 1441 (0.21%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Sialoadenitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 1441 (0.07%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Osteomyelitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    0 / 1441 (0.00%)
    2 / 1445 (0.14%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Streptococcal Bacteraemia
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal Sepsis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superinfection Bacterial
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Typhoid Fever
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    16 / 1441 (1.11%)
    15 / 1445 (1.04%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    9 / 16
    9 / 15
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    4 / 1441 (0.28%)
    7 / 1445 (0.48%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 8
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vestibular Neuronitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 1441 (0.07%)
    3 / 1445 (0.21%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Pharyngitis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vulval Abscess
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound Abscess
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    2 / 1441 (0.14%)
    0 / 1445 (0.00%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased Appetite
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    4 / 1441 (0.28%)
    1 / 1445 (0.07%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    10 / 1441 (0.69%)
    6 / 1445 (0.42%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    7 / 1441 (0.49%)
    3 / 1445 (0.21%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    4 / 1445 (0.28%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    4 / 1441 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    6 / 1441 (0.42%)
    1 / 1445 (0.07%)
    6 / 1441 (0.42%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 1441 (0.14%)
    3 / 1445 (0.21%)
    3 / 1441 (0.21%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hyperosmolar Hyperglycaemic State
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    8 / 1441 (0.56%)
    12 / 1445 (0.83%)
    12 / 1441 (0.83%)
         occurrences causally related to treatment / all
    4 / 10
    3 / 12
    4 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Hypokalaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 1441 (0.21%)
    3 / 1445 (0.21%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ketosis
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic Acidosis
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    2 / 1441 (0.14%)
    1 / 1445 (0.07%)
    2 / 1441 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metabolic Disorder
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic Syndrome
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    3 / 1441 (0.21%)
    5 / 1445 (0.35%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 1441 (0.00%)
    1 / 1445 (0.07%)
    1 / 1441 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 1441 (0.07%)
    0 / 1445 (0.00%)
    0 / 1441 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Canagliflozin 100 mg Canagliflozin 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1137 / 1441 (78.90%)
    1146 / 1445 (79.31%)
    1167 / 1441 (80.99%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    123 / 1441 (8.54%)
    77 / 1445 (5.33%)
    75 / 1441 (5.20%)
         occurrences all number
    163
    103
    91
    Hypotension
         subjects affected / exposed
    15 / 1441 (1.04%)
    39 / 1445 (2.70%)
    54 / 1441 (3.75%)
         occurrences all number
    17
    43
    57
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    24 / 1441 (1.67%)
    30 / 1445 (2.08%)
    38 / 1441 (2.64%)
         occurrences all number
    26
    33
    41
    Chest Pain
         subjects affected / exposed
    57 / 1441 (3.96%)
    63 / 1445 (4.36%)
    61 / 1441 (4.23%)
         occurrences all number
    70
    77
    72
    Fatigue
         subjects affected / exposed
    57 / 1441 (3.96%)
    59 / 1445 (4.08%)
    59 / 1441 (4.09%)
         occurrences all number
    69
    72
    67
    Oedema Peripheral
         subjects affected / exposed
    86 / 1441 (5.97%)
    54 / 1445 (3.74%)
    62 / 1441 (4.30%)
         occurrences all number
    103
    60
    71
    Pyrexia
         subjects affected / exposed
    47 / 1441 (3.26%)
    39 / 1445 (2.70%)
    35 / 1441 (2.43%)
         occurrences all number
    60
    44
    45
    Thirst
         subjects affected / exposed
    1 / 1441 (0.07%)
    19 / 1445 (1.31%)
    29 / 1441 (2.01%)
         occurrences all number
    1
    20
    32
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    25 / 1441 (1.73%)
    87 / 1445 (6.02%)
    100 / 1441 (6.94%)
         occurrences all number
    29
    144
    181
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    29 / 1441 (2.01%)
    37 / 1445 (2.56%)
    36 / 1441 (2.50%)
         occurrences all number
    29
    38
    37
    Vulvovaginal Pruritus
         subjects affected / exposed
    7 / 1441 (0.49%)
    29 / 1445 (2.01%)
    21 / 1441 (1.46%)
         occurrences all number
    7
    43
    35
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    104 / 1441 (7.22%)
    103 / 1445 (7.13%)
    97 / 1441 (6.73%)
         occurrences all number
    145
    120
    115
    Dyspnoea
         subjects affected / exposed
    47 / 1441 (3.26%)
    39 / 1445 (2.70%)
    42 / 1441 (2.91%)
         occurrences all number
    55
    44
    58
    Oropharyngeal Pain
         subjects affected / exposed
    33 / 1441 (2.29%)
    41 / 1445 (2.84%)
    34 / 1441 (2.36%)
         occurrences all number
    40
    49
    40
    Psychiatric disorders
    Depression
         subjects affected / exposed
    33 / 1441 (2.29%)
    39 / 1445 (2.70%)
    38 / 1441 (2.64%)
         occurrences all number
    34
    42
    43
    Insomnia
         subjects affected / exposed
    37 / 1441 (2.57%)
    29 / 1445 (2.01%)
    39 / 1441 (2.71%)
         occurrences all number
    37
    33
    41
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    31 / 1441 (2.15%)
    20 / 1445 (1.38%)
    19 / 1441 (1.32%)
         occurrences all number
    34
    20
    21
    Blood Creatinine Increased
         subjects affected / exposed
    28 / 1441 (1.94%)
    33 / 1445 (2.28%)
    35 / 1441 (2.43%)
         occurrences all number
    30
    36
    40
    Blood Pressure Increased
         subjects affected / exposed
    35 / 1441 (2.43%)
    17 / 1445 (1.18%)
    19 / 1441 (1.32%)
         occurrences all number
    44
    18
    22
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    34 / 1441 (2.36%)
    38 / 1445 (2.63%)
    36 / 1441 (2.50%)
         occurrences all number
    43
    48
    42
    Ligament Sprain
         subjects affected / exposed
    24 / 1441 (1.67%)
    33 / 1445 (2.28%)
    19 / 1441 (1.32%)
         occurrences all number
    27
    36
    23
    Limb Injury
         subjects affected / exposed
    33 / 1441 (2.29%)
    31 / 1445 (2.15%)
    26 / 1441 (1.80%)
         occurrences all number
    39
    33
    32
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    36 / 1441 (2.50%)
    25 / 1445 (1.73%)
    30 / 1441 (2.08%)
         occurrences all number
    40
    32
    40
    Atrial Fibrillation
         subjects affected / exposed
    38 / 1441 (2.64%)
    38 / 1445 (2.63%)
    29 / 1441 (2.01%)
         occurrences all number
    42
    48
    35
    Nervous system disorders
    Diabetic Neuropathy
         subjects affected / exposed
    40 / 1441 (2.78%)
    34 / 1445 (2.35%)
    41 / 1441 (2.85%)
         occurrences all number
    43
    38
    44
    Dizziness
         subjects affected / exposed
    33 / 1441 (2.29%)
    34 / 1445 (2.35%)
    61 / 1441 (4.23%)
         occurrences all number
    41
    40
    85
    Headache
         subjects affected / exposed
    108 / 1441 (7.49%)
    90 / 1445 (6.23%)
    100 / 1441 (6.94%)
         occurrences all number
    155
    111
    137
    Hypoaesthesia
         subjects affected / exposed
    19 / 1441 (1.32%)
    34 / 1445 (2.35%)
    24 / 1441 (1.67%)
         occurrences all number
    21
    37
    26
    Neuropathy Peripheral
         subjects affected / exposed
    26 / 1441 (1.80%)
    33 / 1445 (2.28%)
    24 / 1441 (1.67%)
         occurrences all number
    27
    38
    25
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    55 / 1441 (3.82%)
    41 / 1445 (2.84%)
    40 / 1441 (2.78%)
         occurrences all number
    62
    44
    40
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    42 / 1441 (2.91%)
    50 / 1445 (3.46%)
    54 / 1441 (3.75%)
         occurrences all number
    46
    59
    73
    Eye disorders
    Cataract
         subjects affected / exposed
    77 / 1441 (5.34%)
    91 / 1445 (6.30%)
    84 / 1441 (5.83%)
         occurrences all number
    90
    116
    108
    Diabetic Retinopathy
         subjects affected / exposed
    46 / 1441 (3.19%)
    45 / 1445 (3.11%)
    50 / 1441 (3.47%)
         occurrences all number
    51
    51
    52
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    40 / 1441 (2.78%)
    42 / 1445 (2.91%)
    47 / 1441 (3.26%)
         occurrences all number
    49
    48
    51
    Abdominal Pain Upper
         subjects affected / exposed
    35 / 1441 (2.43%)
    33 / 1445 (2.28%)
    31 / 1441 (2.15%)
         occurrences all number
    53
    38
    36
    Constipation
         subjects affected / exposed
    61 / 1441 (4.23%)
    73 / 1445 (5.05%)
    70 / 1441 (4.86%)
         occurrences all number
    68
    84
    81
    Diarrhoea
         subjects affected / exposed
    119 / 1441 (8.26%)
    105 / 1445 (7.27%)
    147 / 1441 (10.20%)
         occurrences all number
    168
    133
    195
    Dyspepsia
         subjects affected / exposed
    46 / 1441 (3.19%)
    43 / 1445 (2.98%)
    32 / 1441 (2.22%)
         occurrences all number
    52
    51
    35
    Gastritis
         subjects affected / exposed
    31 / 1441 (2.15%)
    44 / 1445 (3.04%)
    38 / 1441 (2.64%)
         occurrences all number
    33
    53
    40
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    32 / 1441 (2.22%)
    41 / 1445 (2.84%)
    46 / 1441 (3.19%)
         occurrences all number
    34
    42
    48
    Nausea
         subjects affected / exposed
    57 / 1441 (3.96%)
    60 / 1445 (4.15%)
    58 / 1441 (4.02%)
         occurrences all number
    77
    82
    77
    Toothache
         subjects affected / exposed
    31 / 1441 (2.15%)
    38 / 1445 (2.63%)
    32 / 1441 (2.22%)
         occurrences all number
    38
    45
    40
    Vomiting
         subjects affected / exposed
    39 / 1441 (2.71%)
    42 / 1445 (2.91%)
    39 / 1441 (2.71%)
         occurrences all number
    45
    49
    45
    Hepatobiliary disorders
    Hepatic Steatosis
         subjects affected / exposed
    32 / 1441 (2.22%)
    18 / 1445 (1.25%)
    20 / 1441 (1.39%)
         occurrences all number
    32
    18
    20
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    37 / 1441 (2.57%)
    19 / 1445 (1.31%)
    30 / 1441 (2.08%)
         occurrences all number
    49
    24
    32
    Rash
         subjects affected / exposed
    28 / 1441 (1.94%)
    38 / 1445 (2.63%)
    45 / 1441 (3.12%)
         occurrences all number
    37
    50
    51
    Skin Lesion
         subjects affected / exposed
    8 / 1441 (0.56%)
    16 / 1445 (1.11%)
    30 / 1441 (2.08%)
         occurrences all number
    9
    24
    37
    Skin Ulcer
         subjects affected / exposed
    31 / 1441 (2.15%)
    45 / 1445 (3.11%)
    51 / 1441 (3.54%)
         occurrences all number
    36
    60
    87
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    15 / 1441 (1.04%)
    30 / 1445 (2.08%)
    32 / 1441 (2.22%)
         occurrences all number
    20
    32
    35
    Pollakiuria
         subjects affected / exposed
    19 / 1441 (1.32%)
    66 / 1445 (4.57%)
    86 / 1441 (5.97%)
         occurrences all number
    21
    67
    91
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    125 / 1441 (8.67%)
    133 / 1445 (9.20%)
    129 / 1441 (8.95%)
         occurrences all number
    156
    157
    161
    Back Pain
         subjects affected / exposed
    137 / 1441 (9.51%)
    138 / 1445 (9.55%)
    149 / 1441 (10.34%)
         occurrences all number
    172
    190
    183
    Muscle Spasms
         subjects affected / exposed
    52 / 1441 (3.61%)
    40 / 1445 (2.77%)
    52 / 1441 (3.61%)
         occurrences all number
    55
    46
    58
    Musculoskeletal Pain
         subjects affected / exposed
    65 / 1441 (4.51%)
    69 / 1445 (4.78%)
    64 / 1441 (4.44%)
         occurrences all number
    71
    80
    82
    Myalgia
         subjects affected / exposed
    43 / 1441 (2.98%)
    49 / 1445 (3.39%)
    36 / 1441 (2.50%)
         occurrences all number
    48
    58
    39
    Neck Pain
         subjects affected / exposed
    22 / 1441 (1.53%)
    20 / 1445 (1.38%)
    30 / 1441 (2.08%)
         occurrences all number
    26
    21
    31
    Osteoarthritis
         subjects affected / exposed
    84 / 1441 (5.83%)
    83 / 1445 (5.74%)
    83 / 1441 (5.76%)
         occurrences all number
    96
    99
    91
    Pain in Extremity
         subjects affected / exposed
    98 / 1441 (6.80%)
    105 / 1445 (7.27%)
    92 / 1441 (6.38%)
         occurrences all number
    114
    123
    127
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    123 / 1441 (8.54%)
    109 / 1445 (7.54%)
    112 / 1441 (7.77%)
         occurrences all number
    183
    140
    152
    Cellulitis
         subjects affected / exposed
    26 / 1441 (1.80%)
    37 / 1445 (2.56%)
    37 / 1441 (2.57%)
         occurrences all number
    28
    53
    54
    Conjunctivitis
         subjects affected / exposed
    22 / 1441 (1.53%)
    34 / 1445 (2.35%)
    24 / 1441 (1.67%)
         occurrences all number
    23
    46
    27
    Cystitis
         subjects affected / exposed
    23 / 1441 (1.60%)
    35 / 1445 (2.42%)
    34 / 1441 (2.36%)
         occurrences all number
    31
    48
    53
    Gastroenteritis
         subjects affected / exposed
    42 / 1441 (2.91%)
    54 / 1445 (3.74%)
    43 / 1441 (2.98%)
         occurrences all number
    44
    60
    55
    Genital Infection Fungal
         subjects affected / exposed
    6 / 1441 (0.42%)
    19 / 1445 (1.31%)
    30 / 1441 (2.08%)
         occurrences all number
    6
    24
    40
    Influenza
         subjects affected / exposed
    86 / 1441 (5.97%)
    100 / 1445 (6.92%)
    82 / 1441 (5.69%)
         occurrences all number
    115
    129
    105
    Localised Infection
         subjects affected / exposed
    26 / 1441 (1.80%)
    18 / 1445 (1.25%)
    30 / 1441 (2.08%)
         occurrences all number
    29
    21
    43
    Lower Respiratory Tract Infection
         subjects affected / exposed
    33 / 1441 (2.29%)
    32 / 1445 (2.21%)
    28 / 1441 (1.94%)
         occurrences all number
    64
    47
    62
    Nasopharyngitis
         subjects affected / exposed
    220 / 1441 (15.27%)
    225 / 1445 (15.57%)
    203 / 1441 (14.09%)
         occurrences all number
    368
    386
    324
    Pharyngitis
         subjects affected / exposed
    31 / 1441 (2.15%)
    43 / 1445 (2.98%)
    24 / 1441 (1.67%)
         occurrences all number
    37
    63
    26
    Pneumonia
         subjects affected / exposed
    39 / 1441 (2.71%)
    23 / 1445 (1.59%)
    39 / 1441 (2.71%)
         occurrences all number
    43
    24
    54
    Sinusitis
         subjects affected / exposed
    45 / 1441 (3.12%)
    58 / 1445 (4.01%)
    65 / 1441 (4.51%)
         occurrences all number
    64
    76
    94
    Upper Respiratory Tract Infection
         subjects affected / exposed
    163 / 1441 (11.31%)
    157 / 1445 (10.87%)
    133 / 1441 (9.23%)
         occurrences all number
    234
    231
    215
    Urinary Tract Infection
         subjects affected / exposed
    128 / 1441 (8.88%)
    132 / 1445 (9.13%)
    159 / 1441 (11.03%)
         occurrences all number
    237
    218
    249
    Viral Infection
         subjects affected / exposed
    26 / 1441 (1.80%)
    32 / 1445 (2.21%)
    33 / 1441 (2.29%)
         occurrences all number
    30
    35
    40
    Vulvovaginal Mycotic Infection
         subjects affected / exposed
    10 / 1441 (0.69%)
    30 / 1445 (2.08%)
    31 / 1441 (2.15%)
         occurrences all number
    19
    58
    84
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    91 / 1441 (6.32%)
    55 / 1445 (3.81%)
    63 / 1441 (4.37%)
         occurrences all number
    130
    63
    74
    Hypoglycaemia
         subjects affected / exposed
    174 / 1441 (12.07%)
    181 / 1445 (12.53%)
    210 / 1441 (14.57%)
         occurrences all number
    1132
    1526
    1433

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Apr 2010
    The overall reason for Amendment INT-2 was to add data from completed Phase 1 studies. A summary of data that demonstrated no clinically meaningful photosensitizing potential of canagliflozin in humans was added and the photoprotective measures were removed.
    11 Mar 2011
    The overall reason for Amendment INT-3 was to were to address regulatory actions taken with rosiglitazone. Procedures for handling subjects already in the study taking rosiglitazone were added. Also, instructions were added prohibiting randomization of any subject who was taking rosiglitazone within 8 weeks before the prescreening or screening visit.
    08 Sep 2011
    The overall reasons for Amendment INT-4 were to remove the preplanned re-estimation of the sample size for Cohort B and to specify that an interim analysis of the ongoing DIA3008 study was required for reporting of safety data in the initial canagliflozin marketing applications.
    13 Dec 2012
    The overall reason for Amendment INT-5 was that the sponsor had been unblinded to the results of the analysis of the study’s primary (cardiovascular) CV endpoint (major adverse cardiovascular events [MACE] events), which was part of a cross-program CV meta-analysis.
    08 Nov 2013
    The overall reason for Amendment INT-6 was to reflect the changes required for compliance with the US FDA postmarketing requirements for canagliflozin. According to these requirements, a post-approval CV meta-analysis was to occur when at least 688 MACE events (ie, CV death, nonfatal myocardial infarction [MI], nonfatal stroke) on treatment were accumulated from DIA3008 plus a planned similar study (DIA4003: A Randomized, Multicenter, Double- Blind, Parallel, Placebo-Controlled Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects With Type 2 Diabetes Mellitus).
    23 Sep 2015
    The overall reason for Amendment INT-7 was to incorporate a request by Health Authorities to include diabetic ketoacidosis (DKA) safety information and the disposition of subjects with this event.
    05 May 2016
    The overall reason for Amendment INT-8 was to include new safety information and guidance regarding subject management with the event of lower-extremity amputations following a notification from the Independent Data Monitoring Committee (IDMC) regarding an increase in the lower-extremity amputation rate among study subjects in DIA3008 taking canagliflozin compared with placebo.

    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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