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    Clinical Trial Results:
    LEADER® liraglutide effect and action in diabetes: Evaluation of cardiovascular outcome results - A long-term, multi-centre, international, randomised double-blind, placebo-controlled trial to determine liraglutide effects on cardiovascular events.

    Summary
    EudraCT number
    2009-012201-19
    Trial protocol
    FR   IE   SE   DE   NL   FI   AT   GB   CZ   BE   DK   PL   GR   ES   IT  
    Global end of trial date
    17 Dec 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Jan 2017
    First version publication date
    01 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EX2211-3748
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01179048
    WHO universal trial number (UTN)
    U1111-1113-7090
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Allé, Bagsvaerd, Denmark, 2880
    Public contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Global Clinical Registry (GCR, 1452), Novo Nordisk A/S, clinicaltrials@novonordisk.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
    29 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 year and up to 5 years on the incidence of cardiovascular events, as defined by the primary and secondary endpoints in adults with type 2 diabetes that are at high risk for cardiovascular events.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki and ICH Good Clinical Practice.
    Background therapy
    At the discretion of the investigator, subjects were provided standard of care therapy, with the option of adding glucose-lowering or cardiovascular medication to achieve prespecified guideline targets for glycaemic control, blood pressure and lipids.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    31 Aug 2010
    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
    Australia: 222
    Country: Number of subjects enrolled
    Austria: 119
    Country: Number of subjects enrolled
    Belgium: 77
    Country: Number of subjects enrolled
    Brazil: 939
    Country: Number of subjects enrolled
    Canada: 333
    Country: Number of subjects enrolled
    China: 92
    Country: Number of subjects enrolled
    Czech Republic: 55
    Country: Number of subjects enrolled
    Denmark: 167
    Country: Number of subjects enrolled
    Finland: 132
    Country: Number of subjects enrolled
    France: 61
    Country: Number of subjects enrolled
    Germany: 448
    Country: Number of subjects enrolled
    Greece: 86
    Country: Number of subjects enrolled
    India: 401
    Country: Number of subjects enrolled
    Ireland: 40
    Country: Number of subjects enrolled
    Israel: 122
    Country: Number of subjects enrolled
    Italy: 203
    Country: Number of subjects enrolled
    Korea, Republic of: 103
    Country: Number of subjects enrolled
    Mexico: 243
    Country: Number of subjects enrolled
    Netherlands: 153
    Country: Number of subjects enrolled
    Norway: 88
    Country: Number of subjects enrolled
    Poland: 388
    Country: Number of subjects enrolled
    Romania: 252
    Country: Number of subjects enrolled
    Russian Federation: 335
    Country: Number of subjects enrolled
    Serbia: 100
    Country: Number of subjects enrolled
    South Africa: 395
    Country: Number of subjects enrolled
    Spain: 205
    Country: Number of subjects enrolled
    Sweden: 146
    Country: Number of subjects enrolled
    Taiwan: 115
    Country: Number of subjects enrolled
    Turkey: 322
    Country: Number of subjects enrolled
    United Arab Emirates: 31
    Country: Number of subjects enrolled
    United Kingdom: 453
    Country: Number of subjects enrolled
    United States: 2514
    Worldwide total number of subjects
    9340
    EEA total number of subjects
    3073
    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)
    5011
    From 65 to 84 years
    4287
    85 years and over
    42

    Subject disposition

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    Recruitment
    Recruitment details
    410 sites in 32 countries across the 4 regions recruited subjects. Number of sites that recruited subjects is given in parenthesis. Europe (143), North America (135) (US, Canada) , Asia (33) (China, Taiwan, Korea, India) and Rest of the world (99) (Brazil, Mexico, Australia, South Africa, Turkey, Russian Federation, United Arab Emirates).

    Pre-assignment
    Screening details
    Of the 12076 subjects screened, 2002 were screening failures and 456 withdrew before run-in. Of the 9618 subjects who entered the run-in phase, 106 subjects were run-in failures and 172 subjects withdrew prior to randomisation. All subjects received placebo during the run-in period and were instructed how to administer the trial product.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Liraglutide
    Arm description
    Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.
    Arm type
    Experimental

    Investigational medicinal product name
    Victoza®
    Investigational medicinal product code
    Other name
    Liraglutide
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Liraglutide was available at a concentration of 6.0 mg/mL and supplied in a 3 mL disposable peninjector. Liraglutide was administered once daily by subcutaneous injection in the abdomen, thigh or upper arm. Injection could be done at any time of the day and irrespective of meals, but it was recommended to keep the time of injection consistent from day to day. Subjects were started on 0.6 mg of liraglutide. Dose escalation of liraglutide, proceeded to 1.2 mg after one week followed by dose escalation to 1.8 mg after one additional week.

    Arm title
    Placebo
    Arm description
    Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    placebo
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo was available at a concentration of 6.0 mg/mL and supplied in a 3 mL disposable peninjector. Placebo was administered once daily by subcutaneous injection in the abdomen, thigh or upper arm. Injection could be done at any time of the day and irrespective of meals, but it was recommended to keep the time of injection consistent from day to day. Subjects were started on 0.6 mg of placebo. Dose escalation of placebo, proceeded to 1.2 mg after one week followed by dose escalation to 1.8 mg after one additional week.

    Number of subjects in period 1
    Liraglutide Placebo
    Started
    4668
    4672
    Completed
    4529
    4513
    Not completed
    139
    159
         Alive
    127
    142
         Withdrawn - does not allow contact
    4
    8
         Lost to follow-up
    8
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.

    Reporting group values
    Liraglutide Placebo Total
    Number of subjects
    4668 4672 9340
    Age Categorical
    Units: Subjects
        18-64 years
    2512 2499 5011
        From 65-84 years
    2139 2148 4287
        85 years and over
    17 25 42
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    64.2 ( 7.2 ) 64.4 ( 7.2 ) -
    Gender Categorical
    Units: Subjects
        Female
    1657 1680 3337
        Male
    3011 2992 6003

    End points

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    End points reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.

    Primary: Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome).

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    End point title
    Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome).
    End point description
    Subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) from randomisation up to last follow-up. Analysis population: full analysis set included all randomised subjects.
    End point type
    Primary
    End point timeframe
    from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days)
    End point values
    Liraglutide Placebo
    Number of subjects analysed
    4668
    4672
    Units: percentage of subjects
        number (not applicable)
    13
    14.9
    Statistical analysis title
    Non-inferiority test
    Statistical analysis description
    The cox regression analysis estimated the hazard ratio (HR) (liraglutide/placebo) and the 2-sided 95% confidence interval (CI) including treatment group as factor. Non-inferiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the HR was below 1.3 or if the p-value for the one-sided test of H0 (null hypothesis) : HR >=1.3 against Ha (alternative hypothesis): HR <1.3 was less than 2.5% (or equivalent to 5% in two-sided test).
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    9340
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority
    P-value
    < 0.001 [1]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.868
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.778
         upper limit
    0.968
    Notes
    [1] - p-value is reported for one-sided (α-level 0.025) test for non-inferiority (hazard ratio >=1.3).
    Statistical analysis title
    Superiority test
    Statistical analysis description
    If non-inferiority was established for the primary outcome, a test for superiority was performed. Superiority of liraglutide versus placebo was considered confirmed, if the upper limit of the two-sided 95% CI for the hazard ratio was below 1.0 or equivalent if the p-value for the one-sided test of H0 (null hypothesis): HR >=1.0 against Ha (alternative hypothesis): HR <1.0 was less than 2.5% (or equivalent to 5% in two-sided test).
    Comparison groups
    Liraglutide v Placebo
    Number of subjects included in analysis
    9340
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.005 [2]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.868
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.778
         upper limit
    0.968
    Notes
    [2] - p-value is reported for one-sided (α-level 0.025) test for superiority (hazard ratio>=1.0).

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events from randomisation (visit 3; month 0) and until follow up (visit 16; month 60+30 days of post-treatment follow-up).
    Adverse event reporting additional description
    Safety was assessed using the full analysis set which included all randomised subjects. Serious adverse events were systematically collected. Non-serious adverse events included both systematically collected as well as non-systematically collected adverse events.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Liraglutide
    Reporting group description
    Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week upto 42-60 months.

    Serious adverse events
    Liraglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2320 / 4668 (49.70%)
    2354 / 4672 (50.39%)
         number of deaths (all causes)
    382
    447
         number of deaths resulting from adverse events
    382
    447
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Adenocarcinoma gastric
         subjects affected / exposed
    3 / 4668 (0.06%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    14 / 4668 (0.30%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    15 / 15
    11 / 11
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Adenocarcinoma of the cervix
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    4 / 4668 (0.09%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    3 / 3
    1 / 1
    Adrenal adenoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiomyolipoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell unclassifiable lymphoma low grade
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    14 / 4668 (0.30%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    17 / 17
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign anorectal neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of prostate
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign soft tissue neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary adenoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    3 / 4668 (0.06%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer stage 0, with cancer in situ
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer stage III
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bladder squamous cell carcinoma stage unspecified
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    4 / 4668 (0.09%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    4 / 4
    5 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma stage III
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blepharal papilloma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    6 / 4668 (0.13%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    6 / 6
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer in situ
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bronchial carcinoma
         subjects affected / exposed
    3 / 4668 (0.06%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Carcinoid tumour of the small bowel
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cerebellar tumour
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cerebral haemangioma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    5 / 4668 (0.11%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    4 / 4
    1 / 1
    Cholesteatoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholesterol granuloma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrosarcoma metastatic
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Chondrosarcoma recurrent
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia stage 1
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Clear cell renal cell carcinoma
         subjects affected / exposed
    6 / 4668 (0.13%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    13 / 4668 (0.28%)
    16 / 4672 (0.34%)
         occurrences causally related to treatment / all
    14 / 14
    18 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    3 / 4668 (0.06%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    3 / 3
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Colon cancer stage 0
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III stage I
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III stage IV
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Gastric cancer stage III
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giant cell tumour of tendon sheath
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Glioblastoma multiforme
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Glomus tumour
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of spleen
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hairy cell leukaemia
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    3 / 3
    1 / 1
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    5 / 4668 (0.11%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Hypopharyngeal cancer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    11 / 4668 (0.24%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    11 / 11
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large cell lung cancer
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large granular lymphocytosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer stage I
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    6 / 4668 (0.13%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lung cancer metastatic
         subjects affected / exposed
    3 / 4668 (0.06%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    3 / 3
    2 / 2
    Lung carcinoma cell type unspecified stage III
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    2 / 4668 (0.04%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    2 / 2
    10 / 10
         deaths causally related to treatment / all
    2 / 2
    5 / 5
    Lung squamous cell carcinoma stage III
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lung squamous cell carcinoma stage IV
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Malignant glioma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    8 / 4668 (0.17%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    8 / 8
    6 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of pleura
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanocytic naevus
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma malignant
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Metastases to central nervous system
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Metastases to liver
         subjects affected / exposed
    5 / 4668 (0.11%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    6 / 6
    4 / 4
         deaths causally related to treatment / all
    3 / 3
    2 / 2
    Metastases to lung
         subjects affected / exposed
    3 / 4668 (0.06%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Metastases to spine
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Mucinous breast carcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Myxofibrosarcoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm of appendix
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    3 / 4668 (0.06%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Non-Hodgkin's lymphoma recurrent
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma stage III
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    4 / 4668 (0.09%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Non-small cell lung cancer stage I
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Oesophageal adenocarcinoma metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma stage IV
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Oropharyngeal cancer stage IV
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Ovarian epithelial cancer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Ovarian epithelial cancer metastatic
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    4 / 4668 (0.09%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    4 / 4
    7 / 7
         deaths causally related to treatment / all
    4 / 4
    6 / 6
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary serous endometrial carcinoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    4 / 4668 (0.09%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    3 / 4668 (0.06%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phyllodes tumour
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pituitary tumour benign
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    3 / 4668 (0.06%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Plasmacytoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    24 / 4668 (0.51%)
    39 / 4672 (0.83%)
         occurrences causally related to treatment / all
    24 / 24
    39 / 39
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    2 / 4668 (0.04%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    6 / 4668 (0.13%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    4 / 4668 (0.09%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Rectal cancer stage II
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer recurrent
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma stage II
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Small intestine carcinoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Small intestine carcinoma metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    4 / 4668 (0.09%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 4668 (0.02%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 5
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Squamous cell carcinoma of skin
         subjects affected / exposed
    7 / 4668 (0.15%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    8 / 8
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    4 / 4668 (0.09%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the vulva
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    4 / 4668 (0.09%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    4 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    8 / 4668 (0.17%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    8 / 8
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Urinary tract neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyosarcoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord neoplasm
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval neoplasm
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 4668 (0.02%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Air embolism
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    8 / 4668 (0.17%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    8 / 8
    5 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    11 / 4668 (0.24%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    11 / 11
    7 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    3 / 4668 (0.06%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    4 / 4668 (0.09%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Deep vein thrombosis
         subjects affected / exposed
    20 / 4668 (0.43%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    23 / 23
    11 / 11
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Diabetic vascular disorder
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    4 / 4668 (0.09%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    6 / 4668 (0.13%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    7 / 7
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis with polyangiitis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hypertension
         subjects affected / exposed
    32 / 4668 (0.69%)
    25 / 4672 (0.54%)
         occurrences causally related to treatment / all
    36 / 36
    27 / 27
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Hypertensive crisis
         subjects affected / exposed
    14 / 4668 (0.30%)
    12 / 4672 (0.26%)
         occurrences causally related to treatment / all
    18 / 18
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    18 / 4668 (0.39%)
    16 / 4672 (0.34%)
         occurrences causally related to treatment / all
    18 / 18
    17 / 17
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Hypovolaemic shock
         subjects affected / exposed
    2 / 4668 (0.04%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Iliac artery occlusion
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    5 / 4668 (0.11%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    7 / 7
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Labile hypertension
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microangiopathy
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis ischaemic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic shock
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Orthostatic hypotension
         subjects affected / exposed
    10 / 4668 (0.21%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    10 / 10
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating atherosclerotic ulcer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    24 / 4668 (0.51%)
    34 / 4672 (0.73%)
         occurrences causally related to treatment / all
    27 / 27
    38 / 38
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Peripheral artery aneurysm
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    8 / 4668 (0.17%)
    12 / 4672 (0.26%)
         occurrences causally related to treatment / all
    9 / 9
    19 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    4 / 4668 (0.09%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    5 / 5
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral circulatory failure
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    13 / 4668 (0.28%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    14 / 14
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    10 / 4668 (0.21%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    11 / 11
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebosclerosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    5 / 4668 (0.11%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    3 / 3
    0 / 0
    Steal syndrome
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboangiitis obliterans
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis necrotising
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Surgical and medical procedures
    Abdominal panniculectomy
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominoplasty
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    7 / 4668 (0.15%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    8 / 8
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle operation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm repair
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic bypass
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic surgery
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial repair
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stent insertion
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial therapeutic procedure
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula operation
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atherectomy
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker battery replacement
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker removal
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary bypass
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular event prophylaxis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid angioplasty
         subjects affected / exposed
    5 / 4668 (0.11%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery bypass
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stent insertion
         subjects affected / exposed
    6 / 4668 (0.13%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    6 / 6
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
         subjects affected / exposed
    19 / 4668 (0.41%)
    14 / 4672 (0.30%)
         occurrences causally related to treatment / all
    23 / 23
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid revascularisation
         subjects affected / exposed
    6 / 4668 (0.13%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    6 / 6
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral revascularisation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy closure
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary angioplasty
         subjects affected / exposed
    46 / 4668 (0.99%)
    39 / 4672 (0.83%)
         occurrences causally related to treatment / all
    56 / 56
    42 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    110 / 4668 (2.36%)
    112 / 4672 (2.40%)
         occurrences causally related to treatment / all
    117 / 117
    136 / 136
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Coronary artery bypass
         subjects affected / exposed
    84 / 4668 (1.80%)
    102 / 4672 (2.18%)
         occurrences causally related to treatment / all
    86 / 86
    105 / 105
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Coronary revascularisation
         subjects affected / exposed
    120 / 4668 (2.57%)
    132 / 4672 (2.83%)
         occurrences causally related to treatment / all
    144 / 144
    157 / 157
         deaths causally related to treatment / all
    3 / 3
    0 / 0
    Deep brain stimulation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endarterectomy
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric banding
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric bypass
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroplasty
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    2 / 4668 (0.04%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator replacement
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia repair
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic heart disease prophylaxis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint arthroplasty
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee operation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma excision
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device battery replacement
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device change
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve replacement
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity surgery
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic floor repair
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    59 / 4668 (1.26%)
    57 / 4672 (1.22%)
         occurrences causally related to treatment / all
    71 / 71
    66 / 66
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    20 / 4668 (0.43%)
    27 / 4672 (0.58%)
         occurrences causally related to treatment / all
    25 / 25
    29 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery bypass
         subjects affected / exposed
    11 / 4668 (0.24%)
    14 / 4672 (0.30%)
         occurrences causally related to treatment / all
    12 / 12
    19 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stent insertion
         subjects affected / exposed
    7 / 4668 (0.15%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    10 / 10
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral endarterectomy
         subjects affected / exposed
    6 / 4668 (0.13%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    7 / 7
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral revascularisation
         subjects affected / exposed
    29 / 4668 (0.62%)
    36 / 4672 (0.77%)
         occurrences causally related to treatment / all
    33 / 33
    47 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prophylaxis against dehydration
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rehabilitation therapy
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stent placement
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal revascularisation surgery
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin graft
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal decompression
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    3 / 4668 (0.06%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombectomy
         subjects affected / exposed
    0 / 4668 (0.00%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular operation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent insertion
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist surgery
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adhesion
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    9 / 4668 (0.19%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    10 / 10
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    4 / 4668 (0.09%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    4 / 4
    6 / 6
         deaths causally related to treatment / all
    4 / 4
    6 / 6
    Catheter site haemorrhage
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    3 / 4668 (0.06%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    3 / 3
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Chest pain
         subjects affected / exposed
    53 / 4668 (1.14%)
    49 / 4672 (1.05%)
         occurrences causally related to treatment / all
    56 / 56
    52 / 52
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Chills
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    55 / 4668 (1.18%)
    47 / 4672 (1.01%)
         occurrences causally related to treatment / all
    55 / 55
    47 / 47
         deaths causally related to treatment / all
    55 / 55
    47 / 47
    Decreased activity
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device battery issue
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    2 / 4668 (0.04%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device leakage
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    2 / 4668 (0.04%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    3 / 3
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Drug interaction
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Gait disturbance
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Generalised oedema
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Granuloma
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    4 / 4668 (0.09%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Incarcerated hernia
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Local swelling
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mass
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device complication
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metaplasia
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    7 / 4668 (0.15%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    7 / 7
    9 / 9
         deaths causally related to treatment / all
    6 / 6
    9 / 9
    Necrosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    45 / 4668 (0.96%)
    63 / 4672 (1.35%)
         occurrences causally related to treatment / all
    52 / 52
    73 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    6 / 4668 (0.13%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    6 / 6
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    5 / 4668 (0.11%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    6 / 6
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    4 / 4668 (0.09%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    4 / 4
    6 / 6
         deaths causally related to treatment / all
    4 / 4
    6 / 6
    Sudden death
         subjects affected / exposed
    11 / 4668 (0.24%)
    17 / 4672 (0.36%)
         occurrences causally related to treatment / all
    11 / 11
    17 / 17
         deaths causally related to treatment / all
    11 / 11
    17 / 17
    Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Amyloidosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media allergy
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    4 / 4668 (0.09%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Walking disability
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    25 / 4668 (0.54%)
    23 / 4672 (0.49%)
         occurrences causally related to treatment / all
    25 / 25
    23 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital prolapse
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematospermia
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peyronie's disease
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic dysplasia
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    7 / 4668 (0.15%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    7 / 7
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular cyst
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular mass
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular necrosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 4668 (0.02%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    1 / 1
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal fistula
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute interstitial pneumonitis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    13 / 4668 (0.28%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    15 / 15
    13 / 13
         deaths causally related to treatment / all
    1 / 1
    3 / 3
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Acute respiratory failure
         subjects affected / exposed
    22 / 4668 (0.47%)
    18 / 4672 (0.39%)
         occurrences causally related to treatment / all
    23 / 23
    21 / 21
         deaths causally related to treatment / all
    5 / 5
    2 / 2
    Asphyxia
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Aspiration
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    12 / 4668 (0.26%)
    14 / 4672 (0.30%)
         occurrences causally related to treatment / all
    14 / 14
    23 / 23
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Asthmatic crisis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    50 / 4668 (1.07%)
    59 / 4672 (1.26%)
         occurrences causally related to treatment / all
    68 / 68
    82 / 82
         deaths causally related to treatment / all
    3 / 3
    7 / 7
    Chronic respiratory failure
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dependence on respirator
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    20 / 4668 (0.43%)
    32 / 4672 (0.68%)
         occurrences causally related to treatment / all
    21 / 21
    36 / 36
         deaths causally related to treatment / all
    2 / 2
    7 / 7
    Dyspnoea exertional
         subjects affected / exposed
    6 / 4668 (0.13%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    6 / 6
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Epistaxis
         subjects affected / exposed
    8 / 4668 (0.17%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    8 / 8
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatopulmonary syndrome
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    5 / 4668 (0.11%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal dysplasia
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal stenosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Nasal polyps
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngeal polyp
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Non-cardiogenic pulmonary oedema
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal cyst
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal inflammation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    4 / 4668 (0.09%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    4 / 4
    18 / 18
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Pleurisy
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    7 / 4668 (0.15%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    7 / 7
    7 / 7
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Pneumonitis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary cavitation
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    21 / 4668 (0.45%)
    24 / 4672 (0.51%)
         occurrences causally related to treatment / all
    21 / 21
    26 / 26
         deaths causally related to treatment / all
    2 / 2
    5 / 5
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    3 / 4668 (0.06%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    3 / 3
    5 / 5
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Pulmonary mass
         subjects affected / exposed
    3 / 4668 (0.06%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    3 / 3
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    17 / 4668 (0.36%)
    21 / 4672 (0.45%)
         occurrences causally related to treatment / all
    22 / 22
    25 / 25
         deaths causally related to treatment / all
    6 / 6
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    5 / 4668 (0.11%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 0
         deaths causally related to treatment / all
    3 / 3
    0 / 0
    Respiratory failure
         subjects affected / exposed
    18 / 4668 (0.39%)
    19 / 4672 (0.41%)
         occurrences causally related to treatment / all
    20 / 20
    21 / 21
         deaths causally related to treatment / all
    5 / 5
    10 / 10
    Restrictive pulmonary disease
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis hypertrophic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus polyp
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    9 / 4668 (0.19%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    9 / 9
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper airway obstruction
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    3 / 4668 (0.06%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 4668 (0.02%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    4 / 4
    Confusional state
         subjects affected / exposed
    0 / 4668 (0.00%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Depression
         subjects affected / exposed
    9 / 4668 (0.19%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    11 / 11
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 4668 (0.02%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    3 / 4668 (0.06%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Personality disorder
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatisation disorder
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    4 / 4668 (0.09%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bile duct stenosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    3 / 4668 (0.06%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary cirrhosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    5 / 4668 (0.11%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary fistula
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 4668 (0.04%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    3 / 3
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    4 / 4668 (0.09%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    4 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    11 / 4668 (0.24%)
    12 / 4672 (0.26%)
         occurrences causally related to treatment / all
    11 / 11
    12 / 12
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    35 / 4668 (0.75%)
    18 / 4672 (0.39%)
         occurrences causally related to treatment / all
    35 / 35
    19 / 19
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Cholecystitis chronic
         subjects affected / exposed
    8 / 4668 (0.17%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    8 / 8
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    44 / 4668 (0.94%)
    30 / 4672 (0.64%)
         occurrences causally related to treatment / all
    45 / 45
    30 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic hepatic failure
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Chronic hepatitis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cryptogenic cirrhosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder perforation
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    4 / 4668 (0.09%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    4 / 4
    6 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    3 / 4668 (0.06%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatomegaly
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Ammonia increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amylase increased
         subjects affected / exposed
    5 / 4668 (0.11%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    5 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram peripheral
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram coronary
         subjects affected / exposed
    0 / 4668 (0.00%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alcohol increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood calcitonin increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    6 / 4668 (0.13%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    6 / 6
    3 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    8 / 4668 (0.17%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    8 / 8
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood iron decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urea increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac murmur
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular evaluation
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy normal
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Culture urine positive
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Imaging procedure
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory marker increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    3 / 4668 (0.06%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    3 / 3
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular end-diastolic pressure increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    11 / 4668 (0.24%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    11 / 11
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal function test
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Serum ferritin decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant evaluation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine albumin/creatinine ratio increased
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    5 / 4668 (0.11%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Afferent loop syndrome
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    2 / 4668 (0.04%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    2 / 2
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site complication
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asbestosis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder injury
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain herniation
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cardiac valve replacement complication
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve rupture
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0