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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, parallel-group, multicenter, event-driven Phase 3 study to investigate efficacy and safety of finerenone on the reduction of cardiovascular morbidity and mortality in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease in addition to standard of care

    Summary
    EudraCT number
    2015-000950-39
    Trial protocol
    DK   SE   HU   GB   AT   DE   CZ   ES   FI   PT   BE   BG   NL   LT   PL   FR   GR   RO   IE   SK   IT  
    Global end of trial date
    02 Feb 2021

    Results information
    Results version number
    v2(current)
    This version publication date
    04 Jun 2022
    First version publication date
    10 Feb 2022
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    As per NIH comments.

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY94-8862/17530
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02545049
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, ​Leverkusen, Germany, ​D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    02 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective was to: - Demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the time to first occurrence of cardiovascular (CV) mortality and morbidity in subjects with type 2 diabetes mellitus (T2D) and the clinical diagnosis of diabetic kidney disease (DKD).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    Standard of care: individual maximum tolerated labeled dose of either an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB) but not both.
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Sep 2015
    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
    Austria: 95
    Country: Number of subjects enrolled
    Belgium: 78
    Country: Number of subjects enrolled
    Bulgaria: 625
    Country: Number of subjects enrolled
    Switzerland: 26
    Country: Number of subjects enrolled
    Czechia: 163
    Country: Number of subjects enrolled
    Germany: 131
    Country: Number of subjects enrolled
    Denmark: 162
    Country: Number of subjects enrolled
    Spain: 258
    Country: Number of subjects enrolled
    Finland: 104
    Country: Number of subjects enrolled
    France: 47
    Country: Number of subjects enrolled
    United Kingdom: 67
    Country: Number of subjects enrolled
    Greece: 29
    Country: Number of subjects enrolled
    Hungary: 215
    Country: Number of subjects enrolled
    Ireland: 4
    Country: Number of subjects enrolled
    Italy: 241
    Country: Number of subjects enrolled
    Lithuania: 25
    Country: Number of subjects enrolled
    Netherlands: 74
    Country: Number of subjects enrolled
    Norway: 38
    Country: Number of subjects enrolled
    Poland: 145
    Country: Number of subjects enrolled
    Portugal: 80
    Country: Number of subjects enrolled
    Romania: 111
    Country: Number of subjects enrolled
    Russian Federation: 390
    Country: Number of subjects enrolled
    Slovakia: 37
    Country: Number of subjects enrolled
    Sweden: 80
    Country: Number of subjects enrolled
    Turkey: 116
    Country: Number of subjects enrolled
    Ukraine: 163
    Country: Number of subjects enrolled
    Canada: 180
    Country: Number of subjects enrolled
    Puerto Rico: 9
    Country: Number of subjects enrolled
    United States: 918
    Country: Number of subjects enrolled
    China: 325
    Country: Number of subjects enrolled
    Hong Kong: 49
    Country: Number of subjects enrolled
    Israel: 278
    Country: Number of subjects enrolled
    Japan: 503
    Country: Number of subjects enrolled
    Korea, Republic of: 144
    Country: Number of subjects enrolled
    Malaysia: 64
    Country: Number of subjects enrolled
    Philippines: 49
    Country: Number of subjects enrolled
    Singapore: 25
    Country: Number of subjects enrolled
    Thailand: 40
    Country: Number of subjects enrolled
    Taiwan: 101
    Country: Number of subjects enrolled
    Vietnam: 47
    Country: Number of subjects enrolled
    Argentina: 256
    Country: Number of subjects enrolled
    Brazil: 210
    Country: Number of subjects enrolled
    Chile: 72
    Country: Number of subjects enrolled
    Colombia: 187
    Country: Number of subjects enrolled
    Mexico: 116
    Country: Number of subjects enrolled
    Australia: 87
    Country: Number of subjects enrolled
    New Zealand: 56
    Country: Number of subjects enrolled
    South Africa: 132
    Worldwide total number of subjects
    7352
    EEA total number of subjects
    2742
    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)
    3510
    From 65 to 84 years
    3783
    85 years and over
    59

    Subject disposition

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    Recruitment
    Recruitment details
    Study was conducted at multiple centers in 48 countries/regions between 17-Sep-2015 (first subject first visit) and 02-Feb-2021 (last subject last visit).

    Pre-assignment
    Screening details
    Overall, 19381 subjects were screened. Of them,11944 subjects were screening failures and 7437 subjects were randomized. 85 subjects were prospectively excluded from the analyses due to critical GCP violations resulting in 7352 in full analysis set. 7341 subjects received study treatment. 1 subject was assigned to placebo but received finerenone.

    Period 1
    Period 1 title
    Analyzed (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Finerenone
    Arm description
    Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy
    Arm type
    Experimental

    Investigational medicinal product name
    Finerenone
    Investigational medicinal product code
    BAY94-8862
    Other name
    Kerendia
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to < 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study. Study medication was administered once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment.

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo once daily in addition to standard of care therapy
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment

    Number of subjects in period 1
    Finerenone Placebo
    Started
    3686
    3666
    Treated
    3683
    3658
    Completed
    3681
    3653
    Not completed
    5
    13
         Consent withdrawn by subject
    1
    7
         Lost to follow-up
    4
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo once daily in addition to standard of care therapy

    Reporting group values
    Finerenone Placebo Total
    Number of subjects
    3686 3666 7352
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    64.13 ± 9.67 64.13 ± 10 -
    Sex: Female, Male
    Units: Subjects
        Female
    1158 1089 2247
        Male
    2528 2577 5105
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    73 70 143
        Asian
    715 739 1454
        Native Hawaiian or Other Pacific Islander
    17 14 31
        Black or African American
    113 145 258
        White
    2672 2605 5277
        More than one race
    87 86 173
        Unknown or Not Reported
    9 7 16
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    618 603 1221
        Not Hispanic or Latino
    3058 3057 6115
        Unknown or Not Reported
    10 6 16
    Urinary albumin-to-creatinine ratio (UACR)
    Units: milligram/gram (mg/g)
        median (inter-quartile range (Q1-Q3))
    302.36 (105.47 to 749.05) 315.06 (111.24 to 731.01) -
    Estimated glomerular filtration rate (eGFR)
    Units: mL/min/1.73m^2
        arithmetic mean (standard deviation)
    67.62 ± 21.65 67.99 ± 21.74 -

    End points

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    End points reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo once daily in addition to standard of care therapy

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    The FAS comprised all randomized subjects (except those with critical GCP violations).

    Primary: The first occurrence of the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure

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    End point title
    The first occurrence of the composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure
    End point description
    Number of participants with the first occurrence of the primary cardiovascular (CV) composite outcome, CV death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure were reported as descriptive result.
    End point type
    Primary
    End point timeframe
    From randomization up until the first occurrence of the CV composite endpoint, or censoring at the end of the study, with an average study duration of 41 months.
    End point values
    Finerenone Placebo
    Number of subjects analysed
    3686
    3666
    Units: Subjects
        number (not applicable)
    458
    519
    Statistical analysis title
    Primary CV composite endpoint
    Statistical analysis description
    A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    7352
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0264 [1]
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    0.98
    Notes
    [1] - A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.

    Secondary: The first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death

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    End point title
    The first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death
    End point description
    Number of participants with first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease of eGFR ≥40% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
    End point type
    Secondary
    End point timeframe
    From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months
    End point values
    Finerenone Placebo
    Number of subjects analysed
    3686
    3666
    Units: Subjects
        number (not applicable)
    350
    395
    Statistical analysis title
    Secondary 40% renal composite endpoint
    Statistical analysis description
    A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    7352
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    = 0.0689 [3]
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.76
         upper limit
    1.01
    Notes
    [2] - If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.
    [3] - A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.

    Secondary: All-cause hospitalization

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    End point title
    All-cause hospitalization
    End point description
    Number of participants with first occurrence of a hospitalization event were reported as descriptive result.
    End point type
    Secondary
    End point timeframe
    From randomization up until the first occurrence of the hospitalization due to any cause, or censoring at the end of study, with an average study duration of 41 months
    End point values
    Finerenone Placebo
    Number of subjects analysed
    3686
    3666
    Units: Subjects
        number (not applicable)
    1573
    1605
    Statistical analysis title
    All-cause hospitalization
    Statistical analysis description
    A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    7352
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    = 0.3558 [5]
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    1.04
    Notes
    [4] - If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.
    [5] - A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.

    Secondary: All-cause mortality

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    End point title
    All-cause mortality
    End point description
    Number of participants with death due to any cause were reported as descriptive result. Number of participants with outcome death reported here includes deaths occurred after randomization until the end of the study visit. Deaths after end of study visit are not included in this table.
    End point type
    Secondary
    End point timeframe
    From randomization up until death due to any cause, or censoring at the end of the study, with an average study duration of 41 months
    End point values
    Finerenone Placebo
    Number of subjects analysed
    3686
    3666
    Units: Subjects
        number (not applicable)
    333
    370
    Statistical analysis title
    All-cause mortality
    Statistical analysis description
    A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    7352
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    = 0.1337 [7]
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.89
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.77
         upper limit
    1.04
    Notes
    [6] - If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.
    [7] - A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.

    Secondary: Change in urinary albumin-to-creatinine ratio (UACR) from baseline to month 4

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    End point title
    Change in urinary albumin-to-creatinine ratio (UACR) from baseline to month 4
    End point description
    First morning void urine samples were collected to evaluate the urinary albumin-to-creatinine ratio (UACR). Month 4 was the visit closest to day 120 within a time window of 120 ± 30 days after randomization. If no measurements were available in this time window, the participant was excluded from this analysis. Ratio of UACR at Month 4 to UACR at baseline is reported as the change.
    End point type
    Secondary
    End point timeframe
    From baseline up until Month 4
    End point values
    Finerenone Placebo
    Number of subjects analysed
    3521
    3476
    Units: Ratio
        least squares mean (confidence interval 95%)
    0.624 (0.606 to 0.642)
    0.922 (0.896 to 0.949)
    Statistical analysis title
    Change in UACR from baseline to Month 4
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    6997
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    P-value
    < 0.0001 [9]
    Method
    ANCOVA
    Parameter type
    Ratio of least squares means
    Point estimate
    0.676
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    0.704
    Notes
    [8] - If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner.
    [9] - P-value from F-test of equal means between the treatment groups. A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.

    Secondary: The first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death.

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    End point title
    The first occurrence of the composite endpoint of onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death.
    End point description
    Number of participants with first occurrence of the renal composite outcome, onset of kidney failure, a sustained decrease in eGFR of ≥57% from baseline over at least 4 weeks, or renal death were reported as descriptive result.
    End point type
    Secondary
    End point timeframe
    From randomization up until the first occurrence of the renal composite endpoint, or censoring at the end of the study, with an average study duration of 41 months
    End point values
    Finerenone Placebo
    Number of subjects analysed
    3686
    3666
    Units: Subjects
        number (not applicable)
    108
    139
    Statistical analysis title
    Secondary 57% renal composite endpoint
    Statistical analysis description
    A stratified Cox proportional hazards regression model was used to provide a point estimate of the hazard ratio and a corresponding two-sided 95% confidence interval.
    Comparison groups
    Finerenone v Placebo
    Number of subjects included in analysis
    7352
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.0406 [11]
    Method
    Logrank
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.77
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    0.99
    Notes
    [10] - If the treatment effect of the 40% renal composite endpoint was not significant, all other endpoints (i.e. all-cause hospitalization, all-cause mortality, change in UACR from baseline to Month 4, and 57% renal composite endpoint) would be tested in an exploratory manner
    [11] - A hierarchical testing procedure was used for the primary and secondary efficacy endpoints with each variable being tested at the adjusted two-sided significance level of 0.04967388.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After the first dose of study drug up to 3 days after any temporary or permanent interruption of study drug, with an average treatment duration of 36 months
    Adverse event reporting additional description
    Adverse events (AEs) are reported for the safety analysis set (SAF) that comprised all randomized subjects who took at least 1 dose of study drug (except those with critical GCP violations). AEs for all-cause mortality are reported for the FAS and considers all deaths after randomization, including those after the end of study visit.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Finerenone
    Reporting group description
    Subjects received finerenone 10 mg or 20 mg once daily in addition to standard of care therapy

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo once daily in addition to standard of care therapy

    Serious adverse events
    Finerenone Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1158 / 3683 (31.44%)
    1215 / 3658 (33.21%)
         number of deaths (all causes)
    339
    383
         number of deaths resulting from adverse events
    79
    100
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 3683 (0.05%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of prostate
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    11 / 3683 (0.30%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    3 / 3683 (0.08%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    3 / 3683 (0.08%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cervix carcinoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Colon cancer
         subjects affected / exposed
    14 / 3683 (0.38%)
    9 / 3658 (0.25%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Enchondromatosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric cancer
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemangioblastoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.03%)
    0 / 3658 (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
    4 / 3683 (0.11%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to liver
         subjects affected / exposed
    3 / 3683 (0.08%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    5 / 3683 (0.14%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    4 / 3683 (0.11%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory papilloma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Seminoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin papilloma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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
    3 / 3683 (0.08%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour ulceration
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Salivary gland adenoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal cancer metastatic
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ear neoplasm malignant
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer metastatic
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Choroid neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    7 / 3683 (0.19%)
    8 / 3658 (0.22%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Metastases to central nervous system
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer
         subjects affected / exposed
    10 / 3683 (0.27%)
    24 / 3658 (0.66%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign anorectal neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female reproductive neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Rectal neoplasm
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour invasion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    3 / 3683 (0.08%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of spleen
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epithelioid mesothelioma
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    5 / 3683 (0.14%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Hepatocellular carcinoma
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive papillary breast carcinoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Triple negative breast cancer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the parotid gland
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    4 / 3683 (0.11%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    5 / 3683 (0.14%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giant cell arteritis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    12 / 3683 (0.33%)
    22 / 3658 (0.60%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    2 / 3683 (0.05%)
    6 / 3658 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 3683 (0.03%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subclavian steal syndrome
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systolic hypertension
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post thrombotic syndrome
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labile hypertension
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.03%)
    1 / 3658 (0.03%)
         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
    3 / 3683 (0.08%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 3683 (0.03%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    4 / 3683 (0.11%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 3683 (0.05%)
    6 / 3658 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery occlusion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm rupture
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abscess drainage
         subjects affected / exposed
    0 / 3683 (0.00%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm repair
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve replacement
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula operation
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder calculus removal
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neck resection
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    2 / 3683 (0.05%)
    7 / 3658 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circumcision
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery bypass
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Finger amputation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot amputation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    4 / 3683 (0.11%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysterectomy
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia repair
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia repair
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intensive care
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insertion of ambulatory peritoneal catheter
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal fixation of fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    8 / 3683 (0.22%)
    9 / 3658 (0.25%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leg amputation
         subjects affected / exposed
    3 / 3683 (0.08%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma excision
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung lobectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polypectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotidectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radical hysterectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radioactive iodine therapy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of foreign body from larynx
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of internal fixation
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst excision
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal stone removal
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar excision
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Roux loop conversion
         subjects affected / exposed
    3 / 3683 (0.08%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer excision
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal laminectomy
         subjects affected / exposed
    3 / 3683 (0.08%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal decompression
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe amputation
         subjects affected / exposed
    4 / 3683 (0.11%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia repair
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    2 / 3683 (0.05%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polypectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitrectomy
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee operation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder arthroplasty
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary revascularisation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral stent insertion
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radical prostatectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus management
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Preoperative care
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral bladder resection
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurolysis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polypectomy
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Caecum operation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc operation
         subjects affected / exposed
    2 / 3683 (0.05%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve decompression
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin neoplasm excision
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctocolectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brachytherapy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb operation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic surgery
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone operation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemotherapy
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colectomy
         subjects affected / exposed
    3 / 3683 (0.08%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye operation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid operation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric bypass
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele operation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lithotripsy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal operation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth extraction
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein operation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin graft
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal operation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug therapy
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent insertion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    7 / 3683 (0.19%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele repair
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular lens implant
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosurgery
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic stent placement
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery bypass
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal polypectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast conserving surgery
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transcatheter aortic valve implantation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial appendage closure
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic surgery
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cheilectomy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary catheter removal
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal disorder prophylaxis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug delivery device placement
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular stem cell transplant
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    18 / 3683 (0.49%)
    20 / 3658 (0.55%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    8 / 3683 (0.22%)
    6 / 3658 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 6
         deaths causally related to treatment / all
    0 / 8
    1 / 6
    Generalised oedema
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 3683 (0.00%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 3683 (0.03%)
    9 / 3658 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    6 / 3683 (0.16%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral swelling
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 3683 (0.05%)
    8 / 3658 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Oedema due to cardiac disease
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic cyst
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adhesion
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 3683 (0.00%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hanging
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    12 / 3683 (0.33%)
    10 / 3658 (0.27%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast necrosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostatic disorder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal dermatitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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 / 3683 (0.03%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    12 / 3683 (0.33%)
    9 / 3658 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Asphyxia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    4 / 3683 (0.11%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchitis chronic
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    22 / 3683 (0.60%)
    16 / 3658 (0.44%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic respiratory failure
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphonia
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    9 / 3683 (0.24%)
    9 / 3658 (0.25%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    2 / 3683 (0.05%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    5 / 3683 (0.14%)
    7 / 3658 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary congestion
         subjects affected / exposed
    0 / 3683 (0.00%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    6 / 3683 (0.16%)
    11 / 3658 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary hypertension
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 3683 (0.05%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory acidosis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory disorder
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.03%)
    0 / 3658 (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
    6 / 3683 (0.16%)
    9 / 3658 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Sleep apnoea syndrome
         subjects affected / exposed
    5 / 3683 (0.14%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal mass
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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
    4 / 3683 (0.11%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Laryngeal disorder
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic crisis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic hydrothorax
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alveolar lung disease
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung perforation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small airways disease
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Confusional state
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusional disorder, unspecified type
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder due to a general medical condition
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide threat
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device malfunction
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device loosening
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    5 / 3683 (0.14%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary fistula
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    7 / 3683 (0.19%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    9 / 3683 (0.24%)
    7 / 3658 (0.19%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    3 / 3683 (0.08%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    5 / 3683 (0.14%)
    7 / 3658 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic hepatitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatty liver alcoholic
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic failure
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic function abnormal
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Liver disorder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Portal hypertension
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystocholangitis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary biliary cholangitis
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Arthroscopy
         subjects affected / exposed
    0 / 3683 (0.00%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy bladder
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy kidney
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy liver
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy prostate
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    4 / 3683 (0.11%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    4 / 3683 (0.11%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy normal
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Computerised tomogram
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopy
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    4 / 3683 (0.11%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 3683 (0.03%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocrit decreased
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram cerebral
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep study
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure orthostatic decreased
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac function test abnormal
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level below therapeutic
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus test positive
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    0 / 3683 (0.00%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endobronchial ultrasound
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma output increased
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer staging
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiocardiogram
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 test negative
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    6 / 3683 (0.16%)
    6 / 3658 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cartilage injury
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis radiation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    4 / 3683 (0.11%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 3683 (0.08%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    8 / 3683 (0.22%)
    8 / 3658 (0.22%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body aspiration
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    5 / 3683 (0.14%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 3683 (0.00%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury corneal
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple injuries
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Overdose
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation proctitis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 3683 (0.05%)
    5 / 3658 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    4 / 3683 (0.11%)
    4 / 3658 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Scapula fracture
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (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 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    3 / 3683 (0.08%)
    6 / 3658 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    5 / 3683 (0.14%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic ulcer
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 3683 (0.11%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intervertebral disc injury
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal injury
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin injury
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    2 / 3683 (0.05%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular anastomosis aneurysm
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral hyperperfusion syndrome
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat illness
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound contamination
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Procedural haemorrhage
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin wound
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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
    4 / 3683 (0.11%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative delirium
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental restoration failure
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular procedural complication
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive tract procedural complication
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arnold-Chiari malformation
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypospadias
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomatous polyposis coli
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anomaly of middle ear congenital
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (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 myocardial infarction
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    4 / 3683 (0.11%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease mixed
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    3 / 3683 (0.08%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    4 / 3683 (0.11%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    3 / 3683 (0.08%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    0 / 3683 (0.00%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 3683 (0.03%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    5 / 3683 (0.14%)
    10 / 3658 (0.27%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    4 / 3683 (0.11%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    2 / 3683 (0.05%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         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 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor pulmonale chronic
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    5 / 3683 (0.14%)
    6 / 3658 (0.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    2 / 3683 (0.05%)
    2 / 3658 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    3 / 3683 (0.08%)
    3 / 3658 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    2 / 3683 (0.05%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular hypokinesia
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 3683 (0.00%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute coronary syndrome
         subjects affected / exposed
    1 / 3683 (0.03%)
    1 / 3658 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 3683 (0.03%)
    0 / 3658 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve disease