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    Clinical Trial Results:
    Phase 3 Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Evaluation of the Efficacy, Safety, and Tolerability of Bococizumab (PF-04950615), in Reducing the Occurrence of Major Cardiovascular Events in High Risk Subjects

    Summary
    EudraCT number
    		 2013-002795-41
    Trial protocol
    		 GB   NL   FI   IT   DE   CZ   HU   SK   ES   BE   DK   SE   IE  
    Global end of trial date
    17 Feb 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Jun 2018
    First version publication date
    10 Nov 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    B1481038
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01975389
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer, Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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
    14 Sep 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate the superior efficacy of bococizumab (PF-04950615) 150 milligram (mg) administered by the subcutaneous route every 2 weeks compared with placebo in reducing the risk of major cardiovascular (CV) events, a composite endpoint which includes adjudicated and confirmed CV death, non-fatal myocardial infarction (MI), non-fatal stroke, and hospitalization for unstable angina with urgent revascularization in subjects at high or very high risk of major CV events who are on background lipid lowering treatment and have an low-density lipoprotein cholesterol (LDL-C) greater or equal to (>=) 100 (non-high density lipoprotein cholesterol (mg/dL) (2.59 millimole per liter [mmol/L]) or non-high density lipoprotein cholesterol (non-HDL-C) >=130 mg/dL (3.36 mmol/L).
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trials subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 316
    Country: Number of subjects enrolled
    Australia: 133
    Country: Number of subjects enrolled
    Belgium: 154
    Country: Number of subjects enrolled
    Brazil: 323
    Country: Number of subjects enrolled
    Canada: 260
    Country: Number of subjects enrolled
    Chile: 60
    Country: Number of subjects enrolled
    Colombia: 103
    Country: Number of subjects enrolled
    Czech Republic: 189
    Country: Number of subjects enrolled
    Denmark: 134
    Country: Number of subjects enrolled
    Finland: 118
    Country: Number of subjects enrolled
    France: 127
    Country: Number of subjects enrolled
    Germany: 740
    Country: Number of subjects enrolled
    Hungary: 324
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Israel: 199
    Country: Number of subjects enrolled
    Italy: 66
    Country: Number of subjects enrolled
    Korea, Republic of: 54
    Country: Number of subjects enrolled
    Mexico: 234
    Country: Number of subjects enrolled
    Netherlands: 890
    Country: Number of subjects enrolled
    New Zealand: 54
    Country: Number of subjects enrolled
    Poland: 878
    Country: Number of subjects enrolled
    Puerto Rico: 15
    Country: Number of subjects enrolled
    Romania: 187
    Country: Number of subjects enrolled
    Russian Federation: 376
    Country: Number of subjects enrolled
    Slovakia: 261
    Country: Number of subjects enrolled
    South Africa: 365
    Country: Number of subjects enrolled
    Spain: 316
    Country: Number of subjects enrolled
    Sweden: 81
    Country: Number of subjects enrolled
    Switzerland: 36
    Country: Number of subjects enrolled
    Taiwan: 37
    Country: Number of subjects enrolled
    Thailand: 23
    Country: Number of subjects enrolled
    Turkey: 64
    Country: Number of subjects enrolled
    United Kingdom: 238
    Country: Number of subjects enrolled
    United States: 3207
    Worldwide total number of subjects
    10564
    EEA total number of subjects
    4705
    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)
    6004
    From 65 to 84 years
    4504
    85 years and over
    56

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents.

    Pre-assignment
    Screening details
    		 This study was conducted at multiple sites from 29-Oct-2013 to 17-Feb-2017. However, subjects were screened from 13 December 2013 through 01 November 2016.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Arm title
    		 Bococizumab (PF-04950615)
    Arm description
    		 Subjects received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bococizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Number of subjects in period 1
    		Placebo Bococizumab (PF-04950615)
    Started
    5283
    5281
    Treated
    5279
    5276
    Completed
    5031
    5045
    Not completed
    252
    236
         Adverse event, serious fatal
    61
    54
         Consent withdrawn by subject
    90
    76
         Adverse event, non-fatal
    10
    6
         Unspecified
    6
    9
         Lost to follow-up
    81
    86
         Randomized, not completed
    4
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Reporting group title
    Bococizumab (PF-04950615)
    Reporting group description
    		 Subjects received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Reporting group values
    		 Placebo Bococizumab (PF-04950615) Total
    Number of subjects
    		 5283 5281 10564
    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)
    		 2965 3039 6004
        From 65-84 years
    		 2289 2215 4504
        85 years and over
    		 29 27 56
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 62.5 ( 9.5 ) 62.2 ( 9.6 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 1849 1792 3641
        Male
    		 3434 3489 6923
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 852 892 1744
        Not Hispanic or Latino
    		 4430 4387 8817
        Unknown or Not Reported
    		 1 2 3
    Race
    Units: Subjects
        Asian
    		 118 105 223
        Black or African American
    		 246 252 498
        White
    		 4776 4784 9560
        Unknown or Not Reported
    		 143 140 283

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Reporting group title
    Bococizumab (PF-04950615)
    Reporting group description
    		 Subjects received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Primary: Event Rate Per 100 Subject-years for First Occurrence of Major Cardiovascular (CV) Event

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Major Cardiovascular (CV) Event
    End point description
    Event rate per 100 subject-years for first occurrence of major CV event (adjudicated by Adjudication Committee) was reported. Major CV event was defined as any of the following: CV death [defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes] non-fatal MI, non-fatal stroke, and hospitalization for unstable angina needing urgent revascularization. Event rate was calculated as the number of events per 100 subject-years at risk. Full analysis set (FAS) included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Primary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of major CV event (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    4.19 (3.66 to 4.78)
    3.33 (2.86 to 3.86)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% Confidence Interval (CI) were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021469
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.97

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-Fatal Myocardial Infraction (MI) or Non-Fatal Stroke

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-Fatal Myocardial Infraction (MI) or Non-Fatal Stroke
    End point description
    Event rate per 100 subject-years for first occurrence of composite endpoint of CV Death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    3.58 (3.09 to 4.12)
    2.67 (2.25 to 3.14)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007597
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.93

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infraction (MI), Non-Fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infraction (MI), Non-Fatal Stroke or Hospitalization for Unstable Angina Needing Urgent Revascularization
    End point description
    Event rate per 100 subject-years for first occurrence of composite endpoint of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    4.59 (4.03 to 5.20)
    3.76 (3.26 to 4.32)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035958
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.99

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infarction (MI) or Non-Fatal Stroke

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of All-Cause Death, Non-Fatal Myocardial Infarction (MI) or Non-Fatal Stroke
    End point description
    Event rate per 100 subject-years for first occurrence of composite endpoint of all-cause death, non-fatal MI or non-fatal stroke (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of all-cause death, non-fatal MI or non-fatal stroke (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    3.97 (3.45 to 4.54)
    3.09 (2.64 to 3.60)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.015694
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.95

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Hospitalization for Unstable Angina Needing Urgent Revascularization
    End point description
    Event rate per 100 subject-years for first occurrence of hospitalization for unstable angina needing urgent revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina needing urgent revascularization (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.77 (0.56 to 1.05)
    0.73 (0.52 to 1.00)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.814224
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.46

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), Non-Fatal Stroke or Hospitalization for Unstable Angina

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Composite Endpoint of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), Non-Fatal Stroke or Hospitalization for Unstable Angina
    End point description
    Event rate per 100 subject-years for first occurrence of composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. CV death was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    4.35 (3.81 to 4.94)
    3.45 (2.97 to 3.98)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.018053
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.96

    Secondary: Event Rate Per 100 Subject-years for Cardiovascular (CV) Death

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    End point title
    		 Event Rate Per 100 Subject-years for Cardiovascular (CV) Death
    End point description
    Event rate per 100 subject-years for occurrence of CV death (adjudicated by Adjudication Committee) was reported. CV was defined as sudden cardiac death, fatal MI, death due to heart failure, death due to stroke (fatal ischemic stroke or fatal stroke of undetermined etiology), or death due to other CV causes. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of adjudicated and confirmed occurrence of CV death (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.62 (0.43 to 0.87)
    0.51 (0.34 to 0.74)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.446033
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.36

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of any Myocardial Infarction (Fatal or Non-Fatal)

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of any Myocardial Infarction (Fatal or Non-Fatal)
    End point description
    Event rate per 100 subject-years for first occurrence of any MI (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of any MI (fatal or non-fatal) (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    2.39 (2.00 to 2.84)
    1.79 (1.45 to 2.19)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.029977
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.97

    Secondary: Event Rate Per 100 Subject-years for Fatal Myocardial Infarction (MI)

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    End point title
    		 Event Rate Per 100 Subject-years for Fatal Myocardial Infarction (MI)
    End point description
    Event rate per 100 subject-years for occurrence of fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of adjudicated and confirmed occurrence of fatal MI (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.16 (0.08 to 0.31)
    0.07 (0.02 to 0.19)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.162615
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.14
         upper limit
    		 1.44

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Non-Fatal Myocardial Infarction (MI)

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Non-Fatal Myocardial Infarction (MI)
    End point description
    Event rate per 100 subject-years for first occurrence of non-fatal MI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of non-fatal MI (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    2.26 (1.88 to 2.70)
    1.74 (1.40 to 2.12)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051534
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 1

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of any Stroke (Fatal or Non-Fatal)

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of any Stroke (Fatal or Non-Fatal)
    End point description
    Event rate per 100 subject-years for first occurrence of any stroke (fatal or non-fatal) (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.72 (0.51 to 0.98)
    0.48 (0.31 to 0.70)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.104998
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.09

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of any Stroke (Fatal or Non-Fatal), of any Etiology

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of any Stroke (Fatal or Non-Fatal), of any Etiology
    End point description
    Event rate per 100 subject-years for first occurrence of any stroke (fatal or non-fatal) of any etiology (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of any stroke (fatal or non-fatal) of any etiology (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.77 (0.56 to 1.04)
    0.61 (0.42 to 0.85)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.294331
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.24

    Secondary: Event Rate Per 100 Subject-years for Fatal Stroke

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    End point title
    		 Event Rate Per 100 Subject-years for Fatal Stroke
    End point description
    Event rate per 100 subject-years for occurrence of fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of adjudicated and confirmed occurrence of fatal stroke (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.00 (0.00 to 0.05)
    0.00 (0.00 to 0.05)
    No statistical analyses for this end point

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Non-Fatal Stroke

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Non-Fatal Stroke
    End point description
    Event rate per 100 subject-years for first occurrence of non-fatal stroke (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of non-fatal stroke (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.72 (0.51 to 0.98)
    0.48 (0.31 to 0.70)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.104998
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.09

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Hospitalization for Unstable Angina

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Hospitalization for Unstable Angina
    End point description
    Event rate per 100 subject-years for first occurrence of hospitalization for unstable angina (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for unstable angina (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.94 (0.70 to 1.24)
    0.85 (0.62 to 1.13)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6012
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.34

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Hospitalization for Congestive Heart Failure (CHF)
    End point description
    Event rate per 100 subject-years for first occurrence of hospitalization for CHF (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of hospitalization for CHF (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.75 (0.54 to 1.02)
    0.83 (0.60 to 1.11)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.678061
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.67

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Coronary Revascularization

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Coronary Revascularization
    End point description
    Event rate per 100 subject-years for first occurrence of coronary revascularization (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of coronary revascularization (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    4.18 (3.65 to 4.77)
    3.23 (2.76 to 3.75)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.010457
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.94

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Coronary Artery Bypass Graft Surgery (CABG)
    End point description
    Event rate per 100 subject-years for first occurrence of CABG (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of CABG (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    0.48 (0.31 to 0.70)
    0.57 (0.39 to 0.81)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.509847
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 2.01

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of Percutaneous Coronary Intervention (PCI)

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of Percutaneous Coronary Intervention (PCI)
    End point description
    Event rate per 100 subject-years for first occurrence of PCI (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of PCI (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    3.73 (3.23 to 4.28)
    2.70 (2.27 to 3.17)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002981
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.9

    Secondary: Event Rate Per 100 Subject-years for First Occurrence of any Arterial Revascularizations

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    End point title
    		 Event Rate Per 100 Subject-years for First Occurrence of any Arterial Revascularizations
    End point description
    Event rate per 100 subject-years for first occurrence of any arterial revascularizations (adjudicated by Adjudication Committee) was reported. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of first adjudicated and confirmed occurrence of any arterial revascularizations (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    1.51 (1.20 to 1.88)
    1.44 (1.14 to 1.80)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.748975
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.3

    Secondary: Event Rate Per 100 Subject-years for All-cause Death

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    End point title
    		 Event Rate Per 100 Subject-years for All-cause Death
    End point description
    Event rate per 100 subject-years for occurrence of all-cause death (adjudicated by Adjudication Committee) was reported. All-cause death was defined as the death due to any cause during the course of study. Event rate was calculated as the number of events per 100 subject-years at risk. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.
    End point type
    Secondary
    End point timeframe
    From baseline until the date of adjudicated and confirmed occurrence of all-cause death (maximum duration: up to 3.4 years)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Events per 100 subject-years
        number (confidence interval 95%)
    1.06 (0.81 to 1.37)
    0.97 (0.73 to 1.27)
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Hazard ratio and 95% CI were obtained from a Cox proportional hazards model stratified by geographic region and complete statin intolerance with treatment as a covariate.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.626157
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.32

    Secondary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14

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    End point title
    		 Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14
    End point description
    FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified. Here, "Number of subjects analyzed" (N) signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 14
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    4712
    4654
    Units: Percent change
        least squares mean (standard error)
    2.13 ( 0.36 )
    -54.77 ( 0.36 )
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    LS (Least square) mean differences, associated 95% CI, and p-values were from an mixed model repeated measures (MMRM) model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    9366
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -56.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -57.91
         upper limit
    		 -55.89
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51

    Secondary: Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14

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    End point title
    		 Nominal Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 14
    End point description
    FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified. Here, "N” signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 14
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    4712
    4654
    Units: mg/dL
        least squares mean (standard error)
    0.69 ( 0.47 )
    -73.11 ( 0.47 )
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    LS mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    9366
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -73.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -75.11
         upper limit
    		 -72.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.67

    Secondary: Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement

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    End point title
    		 Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Last Post-baseline Measurement
    End point description
    FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified. Here, "N” signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, last post-baseline measurement (any time up to Week 140)
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5242
    5246
    Units: Percent change
        least squares mean (standard error)
    2.90 ( 0.45 )
    -36.41 ( 0.45 )
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    LS-mean difference, associated 95% CI, and p-value were from an analysis of covariance (ANCOVA) model with fixed effects for treatment group, baseline value, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10488
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -39.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -40.55
         upper limit
    		 -38.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.64

    Secondary: Percent Change From Baseline in Lipid Levels at Week 14

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    End point title
    		 Percent Change From Baseline in Lipid Levels at Week 14
    End point description
    Lipids included non-high density lipoprotein cholesterol (non-HDL-C), very low density lipoprotein cholesterol (VLDL-C), remnant lipoprotein cholesterol (RLP-C), apolipoprotein B (Apo B), HDL-C, apolipoprotein A-I (Apo A-I) and total cholesterol. FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified.Here, "n" signifies number of subjects who were evaluable for the specified categories, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 14
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Percent change
    least squares mean (standard error)
        Non-HDL-C (n =4698, 4646)
    1.82 ( 0.34 )
    -50.05 ( 0.34 )
        VLDL-C (n =4711, 4657)
    4.88 ( 0.56 )
    -13.54 ( 0.56 )
        RLP-C (n =4696, 4635)
    8.76 ( 0.81 )
    -20.44 ( 0.81 )
        Apo B (n =4616, 4588)
    1.89 ( 0.35 )
    -49.51 ( 0.35 )
        HDL-C (n =4698, 4647)
    1.05 ( 0.21 )
    7.96 ( 0.21 )
        Apo A-I (n =4617, 4588)
    0.07 ( 0.18 )
    4.46 ( 0.18 )
        Total cholesterol (n =4711, 4658)
    1.26 ( 0.28 )
    -36.72 ( 0.28 )
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Non-HDLC: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -51.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.81
         upper limit
    		 -50.94
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.48
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    VLDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -18.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.96
         upper limit
    		 -16.86
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.79
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    RLP-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -29.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.44
         upper limit
    		 -26.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.14
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Apo B: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -51.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -52.37
         upper limit
    		 -50.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.5
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    HDL-C: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    6.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 6.33
         upper limit
    		 7.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.3
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Apo A-I: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 52 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    4.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.9
         upper limit
    		 4.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.25
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Total cholesterol: LS-mean differences, associated 95% CI, and p-values were from an MMRM model including observations through Week 70 with fixed effects for treatment group, visit, treatment group*visit interaction, baseline value, baseline value*visit interaction, geographic region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    -37.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -38.75
         upper limit
    		 -37.22
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.39

    Secondary: Percent Change From Baseline in Log-Transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14

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    End point title
    		 Percent Change From Baseline in Log-Transformed Triglycerides and Lipoprotein (a) (Lp[a]) at Week 14
    End point description
    FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified. Here, "n" signifies number of subjects who were evaluable for the specified categories, for each arm respectively.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 14
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    5283
    5281
    Units: Percent change
    arithmetic mean (standard deviation)
        Triglycerides (n =4711, 4657)
    -1.4 ( 34.55 )
    -19.7 ( 30.71 )
        Lp(a) (n =4650, 4598)
    -2.0 ( 31.03 )
    -33.3 ( 31.21 )
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Triglycerides: LS-mean differences, associated 95% CI and p-values were from an MMRM model including observations through Week 70 on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 0.83
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    Lp(a): LS-mean differences, associated 95% CI and p-values were from an MMRM model on the Difference of log-transformed observations with fixed effects for treatment group, visit, a treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance. The 95% CI was derived by exponentiating the LS-mean difference confidence interval from the log scale.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    10564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.69

    Secondary: Percent Change From Baseline in Log-Transformed High Sensitivity C-Reactive Protein (hs-CRP) at Week 14

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    End point title
    		 Percent Change From Baseline in Log-Transformed High Sensitivity C-Reactive Protein (hs-CRP) at Week 14
    End point description
    FAS included all subjects who were randomized, excluding who attempted to be randomized more than once into a bococizumab CV outcomes trial (B1481022\B1481038) or attempted to be randomized in more than 1 CV outcomes trial and all subjects enrolled at study Site 3027 where a quality-related event was identified. Here, "N” signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 14
    End point values
    		 Placebo Bococizumab (PF-04950615)
    Number of subjects analysed
    4655
    4620
    Units: Percent change
        arithmetic mean (standard deviation)
    -4.8 ( 83.68 )
    0.3 ( 90.03 )
    Statistical analysis title
    		 Placebo vs Bococizumab (PF-04950615)
    Statistical analysis description
    LS-mean differences, associated 95% CI and p-values were from an MMRM model on the difference of log-transformed observations with fixed effects for treatment group, visit, treatment group*visit interaction, log-transformed baseline value, log-transformed baseline value*visit interaction, geographical region and complete statin intolerance.
    Comparison groups
    Placebo v Bococizumab (PF-04950615)
    Number of subjects included in analysis
    9275
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.002
    Method
    		 MMRM
    Parameter type
    		 LS mean difference
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.09

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 3.4 years
    Adverse event reporting additional description
    Safety analysis set: all subjects who randomized, had atleast 1 dose of study drug, excluding those attempted to randomize more than once in a bococizumab CV outcomes trial (B1481022/B1481038) or attempted to randomize in more than 1 CV outcomes trial, and all subjects enrolled at study Site 3027 where a quality-related event was identified
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Bococizumab (PF-04950615)
    Reporting group description
    		 Subjects received single dose of PF-04950615, 150 milligrams, subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 3 years. Subjects were followed up to 40 days after the last dose.

    Serious adverse events
    		 Bococizumab (PF-04950615) Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    934 / 5276 (17.70%)
    994 / 5279 (18.83%)
         number of deaths (all causes)
    54
    61
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lymph node neoplasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    5 / 5276 (0.09%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    2 / 5276 (0.04%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast neoplasm
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac myxoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
    Additional description: This event was gender specific.
         subjects affected / exposed [1]
    2 / 1792 (0.11%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal neoplasm
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
    Additional description: This event was gender specific.
         subjects affected / exposed [2]
    0 / 1792 (0.00%)
    1 / 1849 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric adenoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer stage IV
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric neoplasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypopharyngeal cancer
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    2 / 5276 (0.04%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung adenocarcinoma stage I
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    3 / 5276 (0.06%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant ascites
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant haemangiopericytoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Metastases to spine
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile squamous cell carcinoma
    Additional description: This event was gender specific.
         subjects affected / exposed [3]
    1 / 3489 (0.03%)
    0 / 3434 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
    Additional description: This event was gender specific.
         subjects affected / exposed [4]
    11 / 3489 (0.32%)
    13 / 3434 (0.38%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cell carcinoma recurrent
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract neoplasm
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
    Additional description: This event was gender specific.
         subjects affected / exposed [5]
    1 / 1792 (0.06%)
    1 / 1849 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    4 / 5276 (0.08%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    4 / 5276 (0.08%)
    8 / 5279 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial rupture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Axillary vein thrombosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Embolism venous
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery embolism
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 5276 (0.04%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 5276 (0.08%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    7 / 5276 (0.13%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    7 / 5276 (0.13%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infarction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    3 / 5276 (0.06%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labile hypertension
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microangiopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    14 / 5276 (0.27%)
    13 / 5279 (0.25%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 5276 (0.02%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    8 / 5276 (0.15%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    4 / 5276 (0.08%)
    8 / 5279 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    10 / 5276 (0.19%)
    14 / 5279 (0.27%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Shock
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pain
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion missed
    Additional description: This event was gender specific.
         subjects affected / exposed [6]
    1 / 1792 (0.06%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    8 / 5276 (0.15%)
    14 / 5279 (0.27%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    9 / 5276 (0.17%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-cardiac chest pain
         subjects affected / exposed
    32 / 5276 (0.61%)
    50 / 5279 (0.95%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 53
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stenosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    5 / 5276 (0.09%)
    8 / 5279 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent restenosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (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
    Anaphylactic reaction
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunosuppression
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Immobile
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    Additional description: This event was gender specific.
         subjects affected / exposed [7]
    2 / 3489 (0.06%)
    2 / 3434 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast hyperplasia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
    Additional description: This event was gender specific.
         subjects affected / exposed [8]
    0 / 1792 (0.00%)
    1 / 1849 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
    Additional description: This event was gender specific.
         subjects affected / exposed [9]
    1 / 1792 (0.06%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysfunctional uterine bleeding
    Additional description: This event was gender specific.
         subjects affected / exposed [10]
    1 / 1792 (0.06%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
    Additional description: This event was gender specific.
         subjects affected / exposed [11]
    1 / 1792 (0.06%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
    Additional description: This event was gender specific.
         subjects affected / exposed [12]
    0 / 1792 (0.00%)
    1 / 1849 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
    Additional description: This event was gender specific.
         subjects affected / exposed [13]
    2 / 3489 (0.06%)
    5 / 3434 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
    Additional description: This event was gender specific.
         subjects affected / exposed [14]
    1 / 1792 (0.06%)
    1 / 1849 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
    Additional description: This event was gender specific.
         subjects affected / exposed [15]
    1 / 1792 (0.06%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
    Additional description: This event was gender specific.
         subjects affected / exposed [16]
    1 / 1792 (0.06%)
    0 / 1849 (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
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    7 / 5276 (0.13%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Asthma
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    17 / 5276 (0.32%)
    14 / 5279 (0.27%)
         occurrences causally related to treatment / all
    0 / 18
    1 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    5 / 5276 (0.09%)
    12 / 5279 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Interstitial lung disease
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal dysplasia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    9 / 5276 (0.17%)
    8 / 5279 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    7 / 5276 (0.13%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Stridor
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord leukoplakia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusional disorder, unspecified type
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    6 / 5276 (0.11%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurologic somatic symptom disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device material issue
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Manufacturing issue
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary fistula
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    5 / 5276 (0.09%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    4 / 5276 (0.08%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    5 / 5276 (0.09%)
    7 / 5279 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder perforation
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood ketone body increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction abnormal
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise test abnormal
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial necrosis marker increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological examination
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal function test abnormal
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcus test positive
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress echocardiogram abnormal
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acoustic shock
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass thrombosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 5276 (0.00%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dural tear
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    7 / 5276 (0.13%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    5 / 5276 (0.09%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    3 / 5276 (0.06%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder injury
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney rupture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 5276 (0.04%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative fever
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative respiratory failure
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture related complication
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic renal injury
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract stoma complication
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (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
    Hydrocele
    Additional description: This event was gender specific.
         subjects affected / exposed [17]
    1 / 3489 (0.03%)
    0 / 3434 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
    Additional description: This event was gender specific.
         subjects affected / exposed [18]
    0 / 3489 (0.00%)
    1 / 3434 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute left ventricular failure
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    9 / 5276 (0.17%)
    7 / 5279 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    64 / 5276 (1.21%)
    92 / 5279 (1.74%)
         occurrences causally related to treatment / all
    1 / 70
    1 / 102
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    30 / 5276 (0.57%)
    40 / 5279 (0.76%)
         occurrences causally related to treatment / all
    1 / 35
    0 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Angina unstable
         subjects affected / exposed
    73 / 5276 (1.38%)
    93 / 5279 (1.76%)
         occurrences causally related to treatment / all
    2 / 83
    3 / 102
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anginal equivalent
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    3 / 5276 (0.06%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    4 / 5276 (0.08%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    3 / 5276 (0.06%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    26 / 5276 (0.49%)
    34 / 5279 (0.64%)
         occurrences causally related to treatment / all
    0 / 27
    1 / 38
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    5 / 5276 (0.09%)
    9 / 5279 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    4 / 5276 (0.08%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    4 / 5276 (0.08%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 5276 (0.02%)
    7 / 5279 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    4 / 5276 (0.08%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac failure
         subjects affected / exposed
    16 / 5276 (0.30%)
    15 / 5279 (0.28%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    24 / 5276 (0.45%)
    31 / 5279 (0.59%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac valve disease
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    29 / 5276 (0.55%)
    31 / 5279 (0.59%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 31
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    5 / 5276 (0.09%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    7 / 5276 (0.13%)
    17 / 5279 (0.32%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery thrombosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diastolic dysfunction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    34 / 5276 (0.64%)
    52 / 5279 (0.99%)
         occurrences causally related to treatment / all
    1 / 34
    3 / 57
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    Myocardial ischaemia
         subjects affected / exposed
    9 / 5276 (0.17%)
    10 / 5279 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    4 / 5276 (0.08%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 5276 (0.06%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systolic dysfunction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    6 / 5276 (0.11%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    5 / 5276 (0.09%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amputation stump pain
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (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
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    12 / 5276 (0.23%)
    14 / 5279 (0.27%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    7 / 5276 (0.13%)
    10 / 5279 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervical radiculopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 5276 (0.06%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fahr's disease
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    5 / 5276 (0.09%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    4 / 5276 (0.08%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegic migraine
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intracranial aneurysm
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic neuropathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    16 / 5276 (0.30%)
    23 / 5279 (0.44%)
         occurrences causally related to treatment / all
    0 / 17
    1 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lacunar infarction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoplegia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root compression
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paralysis recurrent laryngeal nerve
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (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
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral motor neuropathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    3 / 5276 (0.06%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Serotonin syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haematoma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    18 / 5276 (0.34%)
    16 / 5279 (0.30%)
         occurrences causally related to treatment / all
    0 / 18
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    14 / 5276 (0.27%)
    16 / 5279 (0.30%)
         occurrences causally related to treatment / all
    1 / 14
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual field defect
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (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
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    6 / 5276 (0.11%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    3 / 5276 (0.06%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 5276 (0.06%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal infarction
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 5276 (0.06%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    4 / 5276 (0.08%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac artery stenosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum oesophageal
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    5 / 5276 (0.09%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    6 / 5276 (0.11%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    4 / 5276 (0.08%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
    Additional description: This event was gender specific.
         subjects affected / exposed [19]
    0 / 1792 (0.00%)
    1 / 1849 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 5276 (0.08%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal food impaction
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    6 / 5276 (0.11%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    3 / 5276 (0.06%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reactive gastropathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    3 / 5276 (0.06%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    5 / 5276 (0.09%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated umbilical hernia
    Additional description: This event was gender specific.
         subjects affected / exposed [20]
    1 / 1792 (0.06%)
    0 / 1849 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative gastritis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
    Additional description: This event was gender specific.
         subjects affected / exposed [21]
    1 / 1792 (0.06%)
    2 / 1849 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
    Additional description: This event was gender specific.
         subjects affected / exposed [22]
    1 / 1792 (0.06%)
    0 / 1849 (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
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 5276 (0.08%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic angioedema
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic ulcer
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peau d'orange
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash generalised
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    10 / 5276 (0.19%)
    15 / 5279 (0.28%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute prerenal failure
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder diverticulum
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder outlet obstruction
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder spasm
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 5276 (0.00%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 5276 (0.00%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    3 / 5276 (0.06%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 5276 (0.06%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Addison's disease
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back disorder
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    9 / 5276 (0.17%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    7 / 5276 (0.13%)
    8 / 5279 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw cyst
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    6 / 5276 (0.11%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 5276 (0.02%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    17 / 5276 (0.32%)
    16 / 5279 (0.30%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arthritis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 5276 (0.02%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue mass
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    3 / 5276 (0.06%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    4 / 5276 (0.08%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    4 / 5276 (0.08%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous graft site infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 5276 (0.09%)
    7 / 5279 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve vegetation
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    8 / 5276 (0.15%)
    10 / 5279 (0.19%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    6 / 5276 (0.11%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 5276 (0.04%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    3 / 5276 (0.06%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Kidney infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    4 / 5276 (0.08%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung abscess
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    4 / 5276 (0.08%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    28 / 5276 (0.53%)
    35 / 5279 (0.66%)
         occurrences causally related to treatment / all
    0 / 29
    1 / 36
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pneumonia bacterial
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural pneumonia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocystitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    5 / 5276 (0.09%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 5276 (0.04%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sebaceous gland infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    13 / 5276 (0.25%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 5276 (0.04%)
    3 / 5279 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sinusitis
         subjects affected / exposed
    2 / 5276 (0.04%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis bacterial
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tick-borne viral encephalitis
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    9 / 5276 (0.17%)
    15 / 5279 (0.28%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 5276 (0.06%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Viral infection
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 5276 (0.08%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    4 / 5276 (0.08%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    5 / 5276 (0.09%)
    4 / 5279 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 5276 (0.00%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    7 / 5276 (0.13%)
    6 / 5279 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar hyperglycaemic state
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 5276 (0.00%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 5276 (0.04%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 5276 (0.04%)
    2 / 5279 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    1 / 5279 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    1 / 5276 (0.02%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    3 / 5276 (0.06%)
    0 / 5279 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 5276 (0.06%)
    5 / 5279 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The event is gender specific event, hence number of subjects at risk are not equal to the total number of subjects.
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Bococizumab (PF-04950615) Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2453 / 5276 (46.49%)
    2128 / 5279 (40.31%)
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    141 / 5276 (2.67%)
    156 / 5279 (2.96%)
         occurrences all number
    150
    168
    Vascular disorders
    Hypertension
         subjects affected / exposed
    226 / 5276 (4.28%)
    242 / 5279 (4.58%)
         occurrences all number
    242
    257
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    104 / 5276 (1.97%)
    120 / 5279 (2.27%)
         occurrences all number
    115
    125
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    136 / 5276 (2.58%)
    143 / 5279 (2.71%)
         occurrences all number
    161
    157
    Headache
         subjects affected / exposed
    171 / 5276 (3.24%)
    163 / 5279 (3.09%)
         occurrences all number
    211
    183
    General disorders and administration site conditions
    Injection site reaction
         subjects affected / exposed
    617 / 5276 (11.69%)
    68 / 5279 (1.29%)
         occurrences all number
    2274
    166
    Fatigue
         subjects affected / exposed
    141 / 5276 (2.67%)
    134 / 5279 (2.54%)
         occurrences all number
    162
    141
    Injection site erythema
         subjects affected / exposed
    164 / 5276 (3.11%)
    23 / 5279 (0.44%)
         occurrences all number
    449
    26
    Non-cardiac chest pain
         subjects affected / exposed
    89 / 5276 (1.69%)
    111 / 5279 (2.10%)
         occurrences all number
    95
    120
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    133 / 5276 (2.52%)
    136 / 5279 (2.58%)
         occurrences all number
    162
    170
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    118 / 5276 (2.24%)
    104 / 5279 (1.97%)
         occurrences all number
    122
    109
    Dyspnoea
         subjects affected / exposed
    96 / 5276 (1.82%)
    124 / 5279 (2.35%)
         occurrences all number
    105
    126
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    211 / 5276 (4.00%)
    182 / 5279 (3.45%)
         occurrences all number
    229
    193
    Back pain
         subjects affected / exposed
    182 / 5276 (3.45%)
    180 / 5279 (3.41%)
         occurrences all number
    198
    193
    Muscle spasms
         subjects affected / exposed
    108 / 5276 (2.05%)
    109 / 5279 (2.06%)
         occurrences all number
    123
    115
    Myalgia
         subjects affected / exposed
    233 / 5276 (4.42%)
    208 / 5279 (3.94%)
         occurrences all number
    256
    233
    Pain in extremity
         subjects affected / exposed
    125 / 5276 (2.37%)
    120 / 5279 (2.27%)
         occurrences all number
    147
    131
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    167 / 5276 (3.17%)
    159 / 5279 (3.01%)
         occurrences all number
    185
    170
    Nasopharyngitis
         subjects affected / exposed
    236 / 5276 (4.47%)
    227 / 5279 (4.30%)
         occurrences all number
    253
    257
    Upper respiratory tract infection
         subjects affected / exposed
    180 / 5276 (3.41%)
    170 / 5279 (3.22%)
         occurrences all number
    204
    191
    Influenza
         subjects affected / exposed
    157 / 5276 (2.98%)
    112 / 5279 (2.12%)
         occurrences all number
    169
    123
    Urinary tract infection
         subjects affected / exposed
    137 / 5276 (2.60%)
    107 / 5279 (2.03%)
         occurrences all number
    154
    129
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    147 / 5276 (2.79%)
    167 / 5279 (3.16%)
         occurrences all number
    147
    172
    Type 2 diabetes mellitus
         subjects affected / exposed
    109 / 5276 (2.07%)
    126 / 5279 (2.39%)
         occurrences all number
    113
    128

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2014
    1. An efficacy endpoint of any stroke (fatal and non-fatal), of any etiology which included hemorrhagic stroke, was added. 2. More frequent visits for assessment of direct LDL-C and AEs/serious AEs, for subjects who have had investigational product dose frequency modifications to quater 4 week so that the data monitoring committee can monitor more closely, lipid levels in subjects with a history of low levels of LDL-C during the trial was added. 3. Depression assessments was added so as to capture baseline risk for the disorder, given that depression was found fairly frequently in subjects at high risk of cardiovascular events and its presence might alter performance on the planned cognitive assessments. 4. Health care utilization assessments and endpoints was added to evaluate the potential impact of bococizumab on health care resource utilization. 5. Screening laboratory tests, hs-CRP and Lp(a) was added for subjects who had not had a prior cardiovascular event, since these were established risk factors for the occurrence of cardiovascular events. 6. Safety section was modified to clarify further, how serious adverse events were to be reported.
    12 Feb 2016
    1. Clinical secondary objectives and endpoints were updated to reflect an upgrading of the secondary endpoint of a composite endpoint of all-cause death, non-fatal MI and non-fatal stroke to a key secondary endpoint, in consideration of its clinical importance. The secondary endpoint of nominal change in hs-CRP was changed to percent change in hs-CRP. 2. The proposed indication was modified so that the major cardiovascular events reflected components of the primary endpoint. 3. The safety reporting section was revised to reflect the fact that a Pfizer internal serious adverse event triage group will ensure the correct reporting of serious AEs to the Pfizer Drug Safety Unit. 4. The cerebral hemorrhage risk exclusion was modified to clarify that a prior lacunar infarct refers to a prior lacunar stroke, ie, a lacunar infarct which resulted in a stroke. 5. An exclusion criterion of gastric bypass surgery was added, since its presence could complicate the interpretation of metabolic efficacy and safety data. 6. A requirement was added to the protocol that IP should not be administered, if a subject was prescribed a marketed proprotein convertase subtilisin/kexin type 9 inhibitor during the conduct of the study.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Nov 2016
    The trial was terminated prematurely on November 1, 2016, due to the emerging clinical profile and the evolving treatment and market landscape for lipid-lowering agents. These indicated that bococizumab was not likely to provide value to patients, physicians, or shareholders. The decision was not based on a recommendation by the independent Data Monitoring Committee to stop the program.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    As specified in statistical analysis plan, due to discontinuation of the bococizumab clinical development program, health care resource utilization endpoints were not evaluated.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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