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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    		 2012-002414-39
    Trial protocol
    		 HU   NL   DE   NO   SE   AT   CZ   ES   FI   DK   IT   BE   SK   LT   PL   FR   HR  
    Global end of trial date
    22 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Dec 2017
    First version publication date
    07 Dec 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MK-3102-018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01703208
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MK-3102-018: Protocol number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Mar 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the cardiovascular (CV) safety profile of omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo and active comparators across the omarigliptin program with regard to the risk of developing a confirmed event in the primary CV composite endpoint.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Some participants in the Insulin Sub-study received insulin with or without metformin.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Oct 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 104
    Country: Number of subjects enrolled
    Australia: 30
    Country: Number of subjects enrolled
    Austria: 29
    Country: Number of subjects enrolled
    Belgium: 61
    Country: Number of subjects enrolled
    Brazil: 94
    Country: Number of subjects enrolled
    Bulgaria: 73
    Country: Number of subjects enrolled
    Canada: 36
    Country: Number of subjects enrolled
    Chile: 31
    Country: Number of subjects enrolled
    Colombia: 31
    Country: Number of subjects enrolled
    Croatia: 39
    Country: Number of subjects enrolled
    Czech Republic: 118
    Country: Number of subjects enrolled
    Denmark: 24
    Country: Number of subjects enrolled
    Finland: 18
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Georgia: 403
    Country: Number of subjects enrolled
    Germany: 192
    Country: Number of subjects enrolled
    Hong Kong: 105
    Country: Number of subjects enrolled
    Hungary: 62
    Country: Number of subjects enrolled
    Israel: 29
    Country: Number of subjects enrolled
    Italy: 85
    Country: Number of subjects enrolled
    Korea, Republic of: 67
    Country: Number of subjects enrolled
    Lebanon: 57
    Country: Number of subjects enrolled
    Lithuania: 27
    Country: Number of subjects enrolled
    Malaysia: 99
    Country: Number of subjects enrolled
    Mexico: 24
    Country: Number of subjects enrolled
    Netherlands: 50
    Country: Number of subjects enrolled
    New Zealand: 60
    Country: Number of subjects enrolled
    Philippines: 88
    Country: Number of subjects enrolled
    Poland: 117
    Country: Number of subjects enrolled
    Romania: 195
    Country: Number of subjects enrolled
    Russian Federation: 143
    Country: Number of subjects enrolled
    Serbia: 79
    Country: Number of subjects enrolled
    Slovakia: 150
    Country: Number of subjects enrolled
    South Africa: 145
    Country: Number of subjects enrolled
    Spain: 183
    Country: Number of subjects enrolled
    Sweden: 29
    Country: Number of subjects enrolled
    Taiwan: 22
    Country: Number of subjects enrolled
    Ukraine: 192
    Country: Number of subjects enrolled
    United Kingdom: 55
    Country: Number of subjects enrolled
    United States: 845
    Worldwide total number of subjects
    4202
    EEA total number of subjects
    1518
    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)
    2211
    From 65 to 84 years
    1970
    85 years and over
    21

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 559 sites received IEC/IRB approval in 40 countries and 547 were shipped clinical supplies. Of the 559 sites, 525 screened at least 1 participant. An insulin sub-study of MK-3102-018 was performed and included the sub-population of participants receiving ≥20 units/day of background insulin with or without metformin.

    Pre-assignment
    Screening details
    		 On April 8, 2016, Merck & Co. Inc. announced that it would not submit marketing applications for omarigliptin (MK-3102) in the US and Europe for business reasons only. Because of this decision, the MK-3102-018 study was terminated early on May 13, 2016 and due to delays in study close-out the Last-Participant-Last-Visit occurred on March 22, 2017.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Omarigliptin 25 mg
    Arm description
    		 Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
    Investigational medicinal product code
    Other name
    MK-3102
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    25 mg capsule or tablet administered orally once weekly

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo to omarigliptin capsule or tablet administered once weekly.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo to omarigliptin capsule or tablet administered once weekly
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule or tablet administered once weekly

    Number of subjects in period 1
    		Omarigliptin 25 mg Placebo
    Started
    2100
    2102
    Treated
    2092
    2100
    Completed
    0
    0
    Not completed
    2100
    2102
         Adverse event, serious fatal
    61
    48
         Physician decision
    11
    13
         Protocol Deviation
    2
    -
         Site Discontinued Study Participation
    23
    27
         Study Terminated by Sponsor
    1710
    1716
         Consent withdrawn by subject
    205
    209
         Non-Compliance with Study Drug
    1
    -
         Excluded Medication
    1
    2
         Adverse event, non-fatal
    14
    19
         Technical Problems
    -
    1
         Lost to follow-up
    68
    62
         Progressive disease
    2
    2
         Lack of efficacy
    1
    2
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Omarigliptin 25 mg
    Reporting group description
    		 Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to omarigliptin capsule or tablet administered once weekly.

    Reporting group values
    		 Omarigliptin 25 mg Placebo Total
    Number of subjects
    		 2100 2102 4202
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1118 1093 2211
        From 65-84 years
    		 970 1000 1970
        85 years and over
    		 12 9 21
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 63.7 ± 8.5 63.6 ± 8.5 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 639 615 1254
        Male
    		 1461 1487 2948
    Study Specific Characteristic | Hemoglobin A1C %
    Hemoglobin A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).
    Units: Percent
        arithmetic mean (standard deviation)
    		 7.99 ± 0.86 8.03 ± 0.89 -
    Study Specific Characteristic | Fasting Plasma Glucose (FPG)
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 184.1 ± 52.2 179.5 ± 45.7 -

    End points

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    End points reporting groups
    Reporting group title
    Omarigliptin 25 mg
    Reporting group description
    		 Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to omarigliptin capsule or tablet administered once weekly.

    Primary: Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)

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    End point title
    		 Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina) [1]
    End point description
    Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015. The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.
    End point type
    Primary
    End point timeframe
    Up to 156 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this end point.
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2090
    2100
    Units: Participants
    66
    70
    No statistical analyses for this end point

    Primary: Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)

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    End point title
    		 Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke) [2]
    End point description
    Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). The analysis population included all randomized participants who took at least one dose of blinded trial medication.
    End point type
    Primary
    End point timeframe
    Up to 179 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was planned or performed for this end point.
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants
    114
    114
    No statistical analyses for this end point

    Primary: Number of Participants with an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)

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    End point title
    		 Number of Participants with an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)
    End point description
    Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants′ follow-up time to first event. The analysis population included all randomized participants who took at least one dose of blinded trial medication.
    End point type
    Primary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants/100 Person-years
        number (not applicable)
    2.96
    2.97
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on the proportional hazards model that includes treatment as an explanatory factor.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.29

    Primary: Change from Baseline in Hemoglobin A1C (A1C) at Week 18

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    End point title
    		 Change from Baseline in Hemoglobin A1C (A1C) at Week 18
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
    End point type
    Primary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.58 (-0.62 to -0.55)
    -0.16 (-0.19 to -0.12)
    Statistical analysis title
    		 Difference in the least squares means
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -0.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.48
         upper limit
    		 -0.37

    Primary: Change from Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)

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    End point title
    		 Change from Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C. The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
    End point type
    Primary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    535
    509
    Units: Percentage
        least squares mean (confidence interval 95%)
    -0.50 (-0.57 to -0.42)
    -0.11 (-0.19 to -0.03)
    Statistical analysis title
    		 Difference in the LS Means vs Placebo
    Statistical analysis description
    Longitudinal data analysis model including terms for treatment, time and the interaction of time by treatment.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Longitudinal data analysis
    Parameter type
    		 Difference in the LS Means vs Placebo
    Point estimate
    -0.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 -0.27

    Primary: Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 18
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    535
    509
    Units: Percentage of participants
        number (not applicable)
    48.8
    49.9
    Statistical analysis title
    		 Difference in Percent vs. Placebo
    Statistical analysis description
    Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in Percent vs. Placebo
    Point estimate
    -1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 4.9

    Primary: Percentage of Participants Who Discontinued from Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change

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    End point title
    		 Percentage of Participants Who Discontinued from Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.
    End point type
    Primary
    End point timeframe
    Up to Week 18
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    535
    509
    Units: Percentage of participants
        number (not applicable)
    1.1
    0.8
    Statistical analysis title
    		 Difference in Percentage vs. Placebo
    Statistical analysis description
    Based on Miettinen & Nurminen method. The 95% CI was computed only for those endpoints with at least 4 participants having events in one or more treatment groups.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in Percentage vs. Placebo
    Point estimate
    0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 1.7

    Secondary: Number of Participants with an Event of CV-Related Death

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    End point title
    		 Number of Participants with an Event of CV-Related Death
    End point description
    Participants with adjudicated and confirmed AEs of cardiovascular-related death. The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants
    37
    35
    No statistical analyses for this end point

    Secondary: Number of Participants with an Event Per 100 Person-Years of CV-Related Death

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    End point title
    		 Number of Participants with an Event Per 100 Person-Years of CV-Related Death
    End point description
    Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants′ follow-up time to event. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants/100 person-years
        number (not applicable)
    0.94
    0.89
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on the proportional hazards model that includes treatment as an explanatory factor.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 1.68

    Secondary: Number of Participants With an Event of First MI (Fatal and Non-fatal)

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    End point title
    		 Number of Participants With an Event of First MI (Fatal and Non-fatal)
    End point description
    Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants
    52
    60
    No statistical analyses for this end point

    Secondary: Number of Participants with an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)

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    End point title
    		 Number of Participants with an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)
    End point description
    Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants′ follow-up time to first event. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants/100 person-years
        number (not applicable)
    1.34
    1.55
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on the proportional hazards model that includes treatment as an explanatory factor.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.26

    Secondary: Number of Participants With an Event of Stroke (Fatal and Non-fatal)

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    End point title
    		 Number of Participants With an Event of Stroke (Fatal and Non-fatal)
    End point description
    Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants
    32
    34
    No statistical analyses for this end point

    Secondary: Number of Participants with an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)

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    End point title
    		 Number of Participants with an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)
    End point description
    Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants′ follow-up time to event. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants/100 person-years
        number (not applicable)
    0.82
    0.88
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on the proportional hazards model that includes treatment as an explanatory factor.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 1.52

    Secondary: Number of Participants With an Event of All-Cause Death

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    End point title
    		 Number of Participants With an Event of All-Cause Death
    End point description
    All-cause death was death from any cause. The analysis population included all randomized participants who took at least one dose of blinded trial medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants
    64
    50
    No statistical analyses for this end point

    Secondary: Number of Participants with an Event Per 100 Person-Years of the Event of All-Cause Death

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    End point title
    		 Number of Participants with an Event Per 100 Person-Years of the Event of All-Cause Death
    End point description
    All-cause death was death for any cause. Person-years were calculated as the sum of all participants′ follow-up time to event. The analysis population included all randomized participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants/100 Person-years
        number (not applicable)
    1.63
    1.28
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on the proportional hazards model that includes treatment as an explanatory factor.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.85

    Secondary: Change from Baseline in A1C at Week 142

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    End point title
    		 Change from Baseline in A1C at Week 142
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C. The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 142
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Percent
        least squares mean (confidence interval 95%)
    -0.36 (-0.47 to -0.25)
    -0.06 (-0.17 to 0.05)
    Statistical analysis title
    		 Difference in the Least Squares Means
    Statistical analysis description
    Longitudinal Data Analysis (LDA) model including terms for treatment, time, and the interaction of time by treatment.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Difference in the Least Squares Means
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.46
         upper limit
    		 -0.14

    Secondary: Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/mol) at 4 Months

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    End point title
    		 Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/mol) at 4 Months
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Data for this efficacy endpoint was not collected, analyzed or summarized.
    End point type
    Secondary
    End point timeframe
    4 months
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Percentage of participants
        number (not applicable)
    Notes
    [3] - Data for this efficacy endpoint was not collected, analyzed or summarized.
    [4] - Data for this efficacy endpoint was not collected, analyzed or summarized.
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fasting Plasma Glucose (FPG) at 4 months

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    End point title
    		 Change from Baseline in Fasting Plasma Glucose (FPG) at 4 months
    End point description
    This change from baseline reflects the Month 4 FPG minus the Week 0 FPG. Data for this efficacy endpoint was not collected, analyzed or summarized.
    End point type
    Secondary
    End point timeframe
    Baseline and 4 months
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: mg/dL
        least squares mean (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [5] - Data for this efficacy endpoint was not collected, analyzed or summarized.
    [6] - Data for this efficacy endpoint was not collected, analyzed or summarized.
    No statistical analyses for this end point

    Secondary: Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline

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    End point title
    		 Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline
    End point description
    Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months. Data for this efficacy endpoint was not collected, analyzed or summarized.
    End point type
    Secondary
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Weeks
        number (not applicable)
    Notes
    [7] - Data for this efficacy endpoint was not collected, analyzed or summarized.
    [8] - Data for this efficacy endpoint was not collected, analyzed or summarized.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Experienced at Least One Adverse Event

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    End point title
    		 Percentage of Participants Who Experienced at Least One Adverse Event
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all randomized participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 234 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Percentage of participants
        number (not applicable)
    78.3
    76.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Discontinued from Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Discontinued from Study Drug Due to an Adverse Event
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The analysis population included all randomized participants who took at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    Up to 212 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Percentage of participants
        number (not applicable)
    4.1
    3.6
    No statistical analyses for this end point

    Secondary: Change from Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin

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    End point title
    		 Change from Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin
    End point description
    This change from baseline reflects the Week 18 FPG minus the Week 0 FPG. The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 18
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    535
    509
    Units: mg/dL
        least squares mean (confidence interval 95%)
    -6.8 (-12.1 to -1.5)
    -3.6 (-9.1 to 1.8)
    Statistical analysis title
    		 Difference in the least squares means
    Statistical analysis description
    Based on a LDA model including terms for treatment, time and the interaction of time by treatment.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.421
    Method
    		 Longitudinal constrained data analysis
    Parameter type
    		 Difference in the least squares means
    Point estimate
    -3.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.8
         upper limit
    		 4.5

    Secondary: Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/mol) at Week 18 in a Sub-Study of Participants Taking Insulin

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    End point title
    		 Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/mol) at Week 18 in a Sub-Study of Participants Taking Insulin
    End point description
    A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation. The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.
    End point type
    Secondary
    End point timeframe
    18 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    535
    509
    Units: Percentage of participants
        number (confidence interval 95%)
    22.0 (18.5 to 26.1)
    10.2 (7.5 to 13.6)
    Statistical analysis title
    		 Between group rate difference
    Statistical analysis description
    Estimated using standard multiple imputation techniques.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    1044
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001 [9]
    Method
    		 Miettinen & Nurminen method
    Parameter type
    		 Between group rate difference
    Point estimate
    11.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.9
         upper limit
    		 16.8
    Notes
    [9] - Estimated using standard multiple imputation techniques.

    Other pre-specified: Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)

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    End point title
    		 Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)
    End point description
    Participants with adjudicated and confirmed events of first hospitalization for heart failure. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Other pre-specified
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants
    20
    33
    No statistical analyses for this end point

    Other pre-specified: Number of Participants with an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)

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    End point title
    		 Number of Participants with an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)
    End point description
    Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants′ follow-up time to event. The analysis population consisted of all participants who took at least one dose of blinded study medication.
    End point type
    Other pre-specified
    End point timeframe
    Up to 179 weeks
    End point values
    		 Omarigliptin 25 mg Placebo
    Number of subjects analysed
    2092
    2100
    Units: Participants/100 Person-years
        number (not applicable)
    0.51
    0.85
    Statistical analysis title
    		 Hazard Ratio (HR)
    Statistical analysis description
    Based on the proportional hazards model that includes treatment as an explanatory factor.
    Comparison groups
    Omarigliptin 25 mg v Placebo
    Number of subjects included in analysis
    4192
    Analysis specification
    Pre-specified
    Analysis type
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.35
         upper limit
    		 1.05

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 234 weeks
    Adverse event reporting additional description
    Participants with serious adverse events with an incidence > 0% and with >5% non-serious adverse events in one or more treatment groups during the Treatment Period + Post-Treatment Follow-up including Post-21 days after last dose of blinded study treatment for randomized participants receiving one or more doses of study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Omarigliptin 25 mg
    Reporting group description
    		 Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo to omarigliptin capsule or tablet administered once weekly.

    Serious adverse events
    		 Omarigliptin 25 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    512 / 2092 (24.47%)
    503 / 2100 (23.95%)
         number of deaths (all causes)
    65
    50
         number of deaths resulting from adverse events
    1
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    10 / 2100 (0.48%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of eyelid
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign renal neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    5 / 2100 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer in situ
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colorectal cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrooesophageal cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Lung carcinoma cell type unspecified stage IV
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm malignant
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lung squamous cell carcinoma stage II
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic gastric cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm malignant
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    1 / 3
    1 / 1
    Pancreatic carcinoma metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage 0
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small cell lung cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    5 / 2100 (0.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer metastatic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ear neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear neoplasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    8 / 2100 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    14 / 2092 (0.67%)
    10 / 2100 (0.48%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Cardiac death
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Multiple organ dysfunction syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Non-cardiac chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    8 / 2100 (0.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Sudden death
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Vascular stent restenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter site haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast fibrosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital prolapse
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic dysplasia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    5 / 2100 (0.24%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    5 / 2100 (0.24%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sleep apnoea syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute stress disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatic symptom disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced mood disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    6 / 2100 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood sodium decreased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Avulsion fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical peritonitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis radiation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flail chest
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated incisional hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Soft tissue injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury cervical
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Stomal hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial rupture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital claw toe
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalocele
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    7 / 2100 (0.33%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    30 / 2092 (1.43%)
    27 / 2100 (1.29%)
         occurrences causally related to treatment / all
    2 / 35
    0 / 28
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Angina pectoris
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    27 / 2092 (1.29%)
    31 / 2100 (1.48%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    33 / 2092 (1.58%)
    42 / 2100 (2.00%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 46
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    14 / 2092 (0.67%)
    16 / 2100 (0.76%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    9 / 2092 (0.43%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 7
    0 / 2
    Cardiac failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    17 / 2092 (0.81%)
    12 / 2100 (0.57%)
         occurrences causally related to treatment / all
    0 / 21
    1 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Cardiac failure acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac failure chronic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    14 / 2092 (0.67%)
    20 / 2100 (0.95%)
         occurrences causally related to treatment / all
    0 / 16
    1 / 25
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Cardio-respiratory arrest
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Cardiogenic shock
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Cardiomyopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Conduction disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor pulmonale
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    22 / 2092 (1.05%)
    23 / 2100 (1.10%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coronary artery insufficiency
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    9 / 2092 (0.43%)
    6 / 2100 (0.29%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    19 / 2092 (0.91%)
    17 / 2100 (0.81%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 19
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Myocardial ischaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial reperfusion injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silent myocardial infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular tachyarrhythmia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    7 / 2100 (0.33%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral ischaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral small vessel ischaemic disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    9 / 2092 (0.43%)
    9 / 2100 (0.43%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebrovascular insufficiency
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dementia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Encephalopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Headache
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve paralysis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    11 / 2092 (0.53%)
    17 / 2100 (0.81%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lacunar infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meralgia paraesthetica
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelitis transverse
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root compression
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    11 / 2092 (0.53%)
    11 / 2100 (0.52%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paralysis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulation factor deficiency
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness neurosensory
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired oesophageal web
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal spasm
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroenteropathy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric varices haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large intestine polyp
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Noninfective gingivitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated umbilical hernia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    11 / 2092 (0.53%)
    6 / 2100 (0.29%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Calculus urethral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stag horn calculus
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Amyotrophy
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    14 / 2092 (0.67%)
    9 / 2100 (0.43%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess intestinal
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary aspergillosis allergic
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    11 / 2092 (0.53%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic hepatitis C
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis bacterial
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    6 / 2092 (0.29%)
    4 / 2100 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gas gangrene
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIV infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroborreliosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nosocomial infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    35 / 2092 (1.67%)
    31 / 2100 (1.48%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 31
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Pneumonia respiratory syncytial viral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    7 / 2092 (0.33%)
    5 / 2100 (0.24%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Septic shock
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Sinusitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural empyema
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 2092 (0.19%)
    6 / 2100 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 2092 (0.10%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    2 / 2100 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    3 / 2100 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    0 / 2100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 2092 (0.24%)
    7 / 2100 (0.33%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 2092 (0.14%)
    5 / 2100 (0.24%)
         occurrences causally related to treatment / all
    2 / 4
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 2092 (0.00%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 2092 (0.05%)
    1 / 2100 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Omarigliptin 25 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    788 / 2092 (37.67%)
    794 / 2100 (37.81%)
    Investigations
    Blood glucose increased
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    97 / 2092 (4.64%)
    139 / 2100 (6.62%)
         occurrences all number
    139
    199
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    123 / 2092 (5.88%)
    145 / 2100 (6.90%)
         occurrences all number
    167
    195
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    123 / 2092 (5.88%)
    120 / 2100 (5.71%)
         occurrences all number
    163
    150
    Urinary tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    108 / 2092 (5.16%)
    98 / 2100 (4.67%)
         occurrences all number
    131
    141
    Metabolism and nutrition disorders
    Hypoglycaemia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    530 / 2092 (25.33%)
    473 / 2100 (22.52%)
         occurrences all number
    3990
    3688

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Oct 2012
    Amendment 1: The primary reason for this amendment was inclusion of a trial design figure.
    22 Jan 2013
    Amendment 2: The primary reason for this amendment was a modified inclusion criteria and contraception language as results were available from the Phase I trial on drug-drug interaction with oral contraceptives.
    05 Mar 2013
    Amendment 5: Clarified the insulin use allowed in an inclusion criterion.
    26 Feb 2014
    Amendment 3: In order to comply with regulatory guidance in Brazil, the Future Biomedical Research information and procedures in the protocol were removed and were presented in a stand-alone protocol amendment.
    26 Feb 2014
    Amendment 4: In order to comply with regulatory guidance in Brazil, the Future Biomedical Research information were presented in a stand-alone protocol amendment
    13 May 2014
    Amendment 6: • Addition of an insulin sub-study in the sub-population of participants receiving background insulin with or without metformin. • Change in the A1C inclusion criterion to 6.5%-10.0% for potential trial participants who are not on monotherapy or dual combination therapy with sulfonylureas, meglitinides or insulin. • Change in enrollment criteria to allow enrollment of participants on prandial insulin. • Provide guidance on the rescreening of potential trial participants secondary the changes in inclusion and exclusion criteria in the current amendment. • Removal of metformin-specific serum creatinine and estimated glomerular filtration rate (eGFR) exclusion criteria. • Change in the eGFR exclusion from <30 mL/min/1.73 m^2 to <40 mL/min/1.73 m^2 to provide a “window” between the Visit 1 exclusion criterion and the discontinuation criterion of <30 mL/min/1.73 m^2. • Exclusion of potential cardiovascular endpoints from expedited serious adverse event (SAE) reporting.
    03 Nov 2015
    Amendment 7 •The primary change is to extend the length of the trial. •Text is incorporated to allow additional participants (Cohort 2) to be enrolled if required. •Objectives and hypothesis relevant to meeting the United States Food and Drug Administration (US FDA) requirements for the post-approval assessment of cardiovascular (CV) safety were added. •Terminology has been introduced which refers to the stages of the CV safety assessment (Stage 1 and Stage 2), trial data collection periods (Period 1 and Period 2), and participant cohorts (Cohort 1 and Cohort 2). •Updated Power and Sample Size in addition to the Statistical Analysis sections to reflect the US FDA post-approval CV safety requirements.

    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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