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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

    		 Close Top of page
    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).

    		 Close Top of page
    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
    0 / 0
    Cataract operation complication
         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
    Cataract traumatic
         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 vertebral fracture
         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
    Chest injury
         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
    Complications of transplanted kidney
         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
    Concussion
         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
    0 / 0
    0 / 0
    Contusion
         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
    Coronary artery reocclusion
         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
    Coronary artery restenosis
         subjects affected / exposed
    5 / 4668 (0.11%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    5 / 5
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft occlusion
         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
    Craniocerebral injury
         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
    Delayed recovery from anaesthesia
         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
    Dialysis related 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
    Electric 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
    0 / 0
    0 / 0
    Facial bones 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
    Fall
         subjects affected / exposed
    84 / 4668 (1.80%)
    81 / 4672 (1.73%)
         occurrences causally related to treatment / all
    94 / 94
    83 / 83
         deaths causally related to treatment / all
    3 / 3
    4 / 4
    Fat embolism
         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
    Femoral neck fracture
         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
    Femur fracture
         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
    Fibula fracture
         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
    Foot fracture
         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
    Forearm 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
    Fracture displacement
         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
    Frostbite
         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
    Gun shot wound
         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
    Hand fracture
         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
    Head injury
         subjects affected / exposed
    4 / 4668 (0.09%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Heat exhaustion
         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
    Hip fracture
         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
    0 / 0
    0 / 0
    Human bite
         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
    Humerus fracture
         subjects affected / exposed
    1 / 4668 (0.02%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         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
    Incorrect dose administered
         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 of wound
         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
    Injury
         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
    Intentional overdose
         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
    Jaw fracture
         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
    Joint dislocation
         subjects affected / exposed
    4 / 4668 (0.09%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         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
    Ligament rupture
         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
    Ligament sprain
         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
    Limb injury
         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
    Limb traumatic amputation
         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
    Lower limb fracture
         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
    Lumbar vertebral fracture
         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
    Meniscus injury
         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
    Multiple fractures
         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
    Muscle 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
    Muscle strain
         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
    Overdose
         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
    Peripheral arterial reocclusion
         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
    Peripheral artery restenosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post laminectomy 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
    Post procedural 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
    Post procedural haematoma
         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
    Post procedural haematuria
         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
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural hypothyroidism
         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
    Post procedural myocardial infarction
         subjects affected / exposed
    0 / 4668 (0.00%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural pulmonary 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
    1 / 1
    0 / 0
    Post procedural stroke
         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
    Post-traumatic pain
         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
    Postoperative fever
         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
    Postoperative hernia
         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
    Postoperative respiratory failure
         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
    Postoperative thoracic procedure complication
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Postoperative 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
    Postoperative wound complication
         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
    Procedural 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
    Procedural hypotension
         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
    Procedural intestinal perforation
         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
    Procedural 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
    Radiation 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
    1 / 1
    Radius fracture
         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
    Respiratory fume inhalation 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
    1 / 1
    Rib fracture
         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
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    20 / 4668 (0.43%)
    16 / 4672 (0.34%)
         occurrences causally related to treatment / all
    23 / 23
    16 / 16
         deaths causally related to treatment / all
    3 / 3
    3 / 3
    Scapula fracture
         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
    Seroma
         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
    Shunt occlusion
         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
    Skeletal 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
    Soft tissue 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
    Spinal compression fracture
         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
    Spinal cord injury thoracic
         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
    Spinal 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
    Splenic 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
    Stab wound
         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
    Sternal 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
    Subcutaneous haematoma
         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
    Subdural haematoma
         subjects affected / exposed
    5 / 4668 (0.11%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    6 / 6
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    3 / 3
    Subdural haemorrhage
         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
    Tendon rupture
         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
    Thermal burn
         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
    Tibia fracture
         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
    Toxicity to various agents
         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
    Tracheostomy malfunction
         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
    Traumatic arthritis
         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
    Traumatic arthrosis
         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
    Traumatic haematoma
         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
    Traumatic intracranial 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
    Traumatic 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
    Ulna fracture
         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
    Urinary retention postoperative
         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 graft occlusion
         subjects affected / exposed
    3 / 4668 (0.06%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    3 / 3
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    2 / 4668 (0.04%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         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
    Wound
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound decomposition
         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
    Wound dehiscence
         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
    Wound 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
    Wound 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
    Wrist fracture
         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
    Wrong drug administered
         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
    Congenital, familial and genetic disorders
    Arteriovenous malformation
         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
    Atrial septal defect
         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
    Buried penis 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
    Coarctation of the aorta
         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
    Congenital cystic kidney 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
    Dermoid 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
    Hamartoma
         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
    Hydrocele
         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
    Hypertrophic cardiomyopathy
         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
    Intracranial lipoma
         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
    Pancreas divisum
         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
    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
    Tracheo-oesophageal 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
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    37 / 4668 (0.79%)
    54 / 4672 (1.16%)
         occurrences causally related to treatment / all
    41 / 41
    59 / 59
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Acute left ventricular failure
         subjects affected / exposed
    2 / 4668 (0.04%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Acute myocardial infarction
         subjects affected / exposed
    155 / 4668 (3.32%)
    187 / 4672 (4.00%)
         occurrences causally related to treatment / all
    176 / 176
    211 / 211
         deaths causally related to treatment / all
    17 / 17
    26 / 26
    Adams-Stokes syndrome
         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
    Angina pectoris
         subjects affected / exposed
    93 / 4668 (1.99%)
    93 / 4672 (1.99%)
         occurrences causally related to treatment / all
    105 / 105
    106 / 106
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Angina unstable
         subjects affected / exposed
    144 / 4668 (3.08%)
    151 / 4672 (3.23%)
         occurrences causally related to treatment / all
    179 / 179
    180 / 180
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Aortic valve calcification
         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 valve incompetence
         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
    Aortic valve sclerosis
         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 valve stenosis
         subjects affected / exposed
    6 / 4668 (0.13%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    6 / 6
    10 / 10
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Arrhythmia
         subjects affected / exposed
    10 / 4668 (0.21%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    11 / 11
    5 / 5
         deaths causally related to treatment / all
    3 / 3
    0 / 0
    Arrhythmia supraventricular
         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
    Arteriosclerosis coronary artery
         subjects affected / exposed
    7 / 4668 (0.15%)
    12 / 4672 (0.26%)
         occurrences causally related to treatment / all
    7 / 7
    12 / 12
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Atrial fibrillation
         subjects affected / exposed
    89 / 4668 (1.91%)
    97 / 4672 (2.08%)
         occurrences causally related to treatment / all
    113 / 113
    112 / 112
         deaths causally related to treatment / all
    1 / 1
    4 / 4
    Atrial flutter
         subjects affected / exposed
    17 / 4668 (0.36%)
    16 / 4672 (0.34%)
         occurrences causally related to treatment / all
    20 / 20
    18 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         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
    Atrioventricular block
         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
    Atrioventricular block complete
         subjects affected / exposed
    10 / 4668 (0.21%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    10 / 10
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first 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
    Atrioventricular dissociation
         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
    Atrioventricular block second degree
         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
    0 / 0
    0 / 0
    Bradyarrhythmia
         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
    Bradycardia
         subjects affected / exposed
    11 / 4668 (0.24%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    11 / 11
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bundle branch block left
         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
    Bundle branch block right
         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 aneurysm
         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
    Cardiac arrest
         subjects affected / exposed
    20 / 4668 (0.43%)
    31 / 4672 (0.66%)
         occurrences causally related to treatment / all
    20 / 20
    31 / 31
         deaths causally related to treatment / all
    12 / 12
    22 / 22
    Cardiac discomfort
         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
    Cardiac 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
    Cardiac failure
         subjects affected / exposed
    115 / 4668 (2.46%)
    137 / 4672 (2.93%)
         occurrences causally related to treatment / all
    138 / 138
    201 / 201
         deaths causally related to treatment / all
    16 / 16
    21 / 21
    Cardiac failure acute
         subjects affected / exposed
    9 / 4668 (0.19%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    11 / 11
    12 / 12
         deaths causally related to treatment / all
    2 / 2
    2 / 2
    Cardiac failure chronic
         subjects affected / exposed
    28 / 4668 (0.60%)
    25 / 4672 (0.54%)
         occurrences causally related to treatment / all
    28 / 28
    29 / 29
         deaths causally related to treatment / all
    2 / 2
    3 / 3
    Cardiac failure congestive
         subjects affected / exposed
    121 / 4668 (2.59%)
    129 / 4672 (2.76%)
         occurrences causally related to treatment / all
    180 / 180
    176 / 176
         deaths causally related to treatment / all
    8 / 8
    18 / 18
    Cardiac valve 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
    Cardiac ventricular thrombosis
         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
    1 / 1
    Cardio-respiratory arrest
         subjects affected / exposed
    15 / 4668 (0.32%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    15 / 15
    15 / 15
         deaths causally related to treatment / all
    12 / 12
    13 / 13
    Cardiogenic shock
         subjects affected / exposed
    4 / 4668 (0.09%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    4 / 4
    11 / 11
         deaths causally related to treatment / all
    3 / 3
    8 / 8
    Cardiomegaly
         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
    Cardiomyopathy
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Cardiopulmonary failure
         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
    3 / 3
    4 / 4
    Cardiorenal 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
    0 / 0
    Cardiovascular disorder
         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
    2 / 2
    Cardiovascular insufficiency
         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
    Chordae tendinae 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
    Congestive cardiomyopathy
         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
    1 / 1
    Cor pulmonale
         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
    Cor pulmonale acute
         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
    Cor pulmonale chronic
         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 artery disease
         subjects affected / exposed
    73 / 4668 (1.56%)
    87 / 4672 (1.86%)
         occurrences causally related to treatment / all
    77 / 77
    89 / 89
         deaths causally related to treatment / all
    4 / 4
    4 / 4
    Coronary artery insufficiency
         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
    Coronary artery occlusion
         subjects affected / exposed
    16 / 4668 (0.34%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    16 / 16
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    20 / 4668 (0.43%)
    35 / 4672 (0.75%)
         occurrences causally related to treatment / all
    20 / 20
    36 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary ostial stenosis
         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
    Dilatation atrial
         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
    Extrasystoles
         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
    Hypertensive cardiomyopathy
         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
    Hypertensive heart disease
         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
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    3 / 4668 (0.06%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    3 / 3
    9 / 9
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Left ventricular dysfunction
         subjects affected / exposed
    5 / 4668 (0.11%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    5 / 5
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Left ventricular failure
         subjects affected / exposed
    3 / 4668 (0.06%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    3 / 3
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Left ventricular hypertrophy
         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
    0 / 0
    Microvascular coronary artery 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
    Mitral valve calcification
         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 incompetence
         subjects affected / exposed
    3 / 4668 (0.06%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    3 / 3
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    3 / 3
    Mitral valve 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
    Myocardial fibrosis
         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
    Myocardial infarction
         subjects affected / exposed
    68 / 4668 (1.46%)
    84 / 4672 (1.80%)
         occurrences causally related to treatment / all
    71 / 71
    89 / 89
         deaths causally related to treatment / all
    18 / 18
    31 / 31
    Myocardial ischaemia
         subjects affected / exposed
    27 / 4668 (0.58%)
    33 / 4672 (0.71%)
         occurrences causally related to treatment / all
    27 / 27
    35 / 35
         deaths causally related to treatment / all
    1 / 1
    8 / 8
    Myocarditis
         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
    Nodal rhythm
         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
    Palpitations
         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
    Pericardial 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
    Pericardial effusion
         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
    Pericardial 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
    Pericarditis
         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
    0 / 0
    0 / 0
    Pericarditis uraemic
         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
    Pneumopericardium
         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
    Postural orthostatic tachycardia 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
    Rhythm idioventricular
         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
    Right ventricular 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
    0 / 0
    Silent myocardial infarction
         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
    Sinus 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
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 4668 (0.00%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    10 / 4668 (0.21%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    10 / 10
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         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
    Stress cardiomyopathy
         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
    Supraventricular extrasystoles
         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
    Supraventricular tachycardia
         subjects affected / exposed
    9 / 4668 (0.19%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    9 / 9
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systolic dysfunction
         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
    Tachyarrhythmia
         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
    Tachycardia
         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
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 4668 (0.00%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Ventricular arrhythmia
         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
    Ventricular dyssynchrony
         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
    Ventricular extrasystoles
         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
    0 / 0
    Ventricular fibrillation
         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
    1 / 1
    Ventricular hypokinesia
         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
    Ventricular tachyarrhythmia
         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
    Ventricular tachycardia
         subjects affected / exposed
    18 / 4668 (0.39%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    29 / 29
    11 / 11
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Wolff-Parkinson-White 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
    Nervous system disorders
    Altered state of consciousness
         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
    Ataxia
         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
    Autonomic nervous system imbalance
         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
    Basal ganglia haemorrhage
         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
    Basal ganglia stroke
         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 injury
         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
    Brain 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
    1 / 1
    Brain stem infarction
         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
    Carotid arteriosclerosis
         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
    Carotid artery aneurysm
         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
    Carotid artery 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
    Carotid artery occlusion
         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
    Carotid artery stenosis
         subjects affected / exposed
    28 / 4668 (0.60%)
    16 / 4672 (0.34%)
         occurrences causally related to treatment / all
    30 / 30
    18 / 18
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Carpal tunnel syndrome
         subjects affected / exposed
    6 / 4668 (0.13%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    7 / 7
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina 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
    Cerebellar 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
    1 / 1
    Cerebellar infarction
         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
    Cerebellar ischaemia
         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
    Cerebral 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
    1 / 1
    Cerebral haemorrhage
         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
    1 / 1
    Cerebral hypoperfusion
         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
    Cerebral infarction
         subjects affected / exposed
    14 / 4668 (0.30%)
    20 / 4672 (0.43%)
         occurrences causally related to treatment / all
    14 / 14
    21 / 21
         deaths causally related to treatment / all
    2 / 2
    3 / 3
    Cerebral ischaemia
         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
    0 / 0
    0 / 0
    Cerebral small vessel ischaemic disease
         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
    Cerebrovascular accident
         subjects affected / exposed
    52 / 4668 (1.11%)
    65 / 4672 (1.39%)
         occurrences causally related to treatment / all
    56 / 56
    68 / 68
         deaths causally related to treatment / all
    8 / 8
    11 / 11
    Cerebrovascular insufficiency
         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
    Cervical myelopathy
         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 radiculopathy
         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 inflammatory demyelinating polyradiculoneuropathy
         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
    Cognitive disorder
         subjects affected / exposed
    4 / 4668 (0.09%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Coma
         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
    2 / 2
    Dementia
         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
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         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
    Dementia with Lewy bodies
         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
    Depressed level of consciousness
         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
    Diabetic mononeuropathy
         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
    Diabetic neuropathy
         subjects affected / exposed
    9 / 4668 (0.19%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    10 / 10
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    12 / 4668 (0.26%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    12 / 12
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         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
    Dyskinesia
         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
    Embolic cerebral infarction
         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
    Embolic stroke
         subjects affected / exposed
    5 / 4668 (0.11%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         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
    Epilepsy
         subjects affected / exposed
    4 / 4668 (0.09%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    5 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         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
    Guillain-Barre 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
    Haemorrhage intracranial
         subjects affected / exposed
    6 / 4668 (0.13%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    6 / 6
    4 / 4
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Haemorrhagic cerebral infarction
         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
    Haemorrhagic stroke
         subjects affected / exposed
    10 / 4668 (0.21%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    10 / 10
    13 / 13
         deaths causally related to treatment / all
    3 / 3
    7 / 7
    Headache
         subjects affected / exposed
    2 / 4668 (0.04%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         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
    Hemiplegia
         subjects affected / exposed
    1 / 4668 (0.02%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         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
    Hydrocephalus
         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
    Hyperaesthesia
         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
    Hypertensive encephalopathy
         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
    Hypoaesthesia
         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
    Hypoglycaemic coma
         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
    Hypoglycaemic seizure
         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
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    21 / 4668 (0.45%)
    28 / 4672 (0.60%)
         occurrences causally related to treatment / all
    24 / 24
    28 / 28
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    2 / 4668 (0.04%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    IIIrd nerve 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
    Intercostal neuralgia
         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
    Internal carotid artery kinking
         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
    Intracranial aneurysm
         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
    Ischaemic cerebral infarction
         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
    1 / 1
    Ischaemic stroke
         subjects affected / exposed
    50 / 4668 (1.07%)
    54 / 4672 (1.16%)
         occurrences causally related to treatment / all
    54 / 54
    59 / 59
         deaths causally related to treatment / all
    3 / 3
    7 / 7
    Lacunar infarction
         subjects affected / exposed
    6 / 4668 (0.13%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    7 / 7
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         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
    Loss of consciousness
         subjects affected / exposed
    5 / 4668 (0.11%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    6 / 6
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         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
    Memory impairment
         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
    Metabolic encephalopathy
         subjects affected / exposed
    6 / 4668 (0.13%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 4668 (0.00%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mononeuropathy
         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
    Multiple system atrophy
         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
    Myasthenia gravis
         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
    Myelopathy
         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
    Nerve compression
         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
    Nervous system disorder
         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
    Neuralgia
         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
    Neuritis cranial
         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
    Neuropathy peripheral
         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
    Normal pressure hydrocephalus
         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
    Orthostatic intolerance
         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
    Paraplegia
         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
    Parkinson'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
    1 / 1
    0 / 0
    Parkinsonism
         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
    Partial seizures
         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 nerve lesion
         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
    Peroneal nerve palsy
         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
    Petit mal epilepsy
         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
    Polyneuropathy
         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
    Post herpetic neuralgia
         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
    Post-traumatic headache
         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
    Presyncope
         subjects affected / exposed
    6 / 4668 (0.13%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    7 / 7
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         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
    Restless legs syndrome
         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
    Reversible ischaemic neurological deficit
         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
    Sciatica
         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
    Seizure
         subjects affected / exposed
    7 / 4668 (0.15%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    7 / 7
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure like phenomena
         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
    Serotonin 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
    Spinal claudication
         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
    Status epilepticus
         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
    Subarachnoid haemorrhage
         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
    Syncope
         subjects affected / exposed
    39 / 4668 (0.84%)
    26 / 4672 (0.56%)
         occurrences causally related to treatment / all
    43 / 43
    27 / 27
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Tension headache
         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
    Thalamic infarction
         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
    Thrombotic cerebral infarction
         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
    Thrombotic stroke
         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
    Toxic encephalopathy
         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
    Transient ischaemic attack
         subjects affected / exposed
    52 / 4668 (1.11%)
    68 / 4672 (1.46%)
         occurrences causally related to treatment / all
    57 / 57
    73 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unresponsive to stimuli
         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
    Uraemic encephalopathy
         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
    VIIth nerve paralysis
         subjects affected / exposed
    3 / 4668 (0.06%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    3 / 3
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         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
    Vertebral artery stenosis
         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
    Vertebrobasilar insufficiency
         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
    Vocal cord paralysis
         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 and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    31 / 4668 (0.66%)
    21 / 4672 (0.45%)
         occurrences causally related to treatment / all
    32 / 32
    22 / 22
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Anaemia macrocytic
         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 megaloblastic
         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
    Anaemia vitamin B12 deficiency
         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
    Coagulopathy
         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
    Haemolytic anaemia
         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
    Haemorrhagic anaemia
         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
    Hypochromic anaemia
         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
    Immune thrombocytopenic purpura
         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
    Iron deficiency anaemia
         subjects affected / exposed
    9 / 4668 (0.19%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    9 / 9
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         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
    Leukopenia
         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
    Lymphadenopathy
         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
    Microcytic anaemia
         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
    Neutropenia
         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
    Normochromic normocytic anaemia
         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
    Pancytopenia
         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
    Paratracheal lymphadenopathy
         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
    Polycythaemia
         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
    Splenic embolism
         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
    Splenic infarction
         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
    Splenomegaly
         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
    Thrombocytopenia
         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
    Ear and labyrinth disorders
    Aural 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
    Deafness bilateral
         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
    Deafness unilateral
         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
    Eustachian tube dysfunction
         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
    Hypoacusis
         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
    Sudden hearing loss
         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
    Vertigo
         subjects affected / exposed
    6 / 4668 (0.13%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    6 / 6
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         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
    Vestibular 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
    Eye disorders
    Amaurosis
         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
    Angle closure glaucoma
         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
    Aphakia
         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
    Autoimmune uveitis
         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
    Blepharitis
         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
    Blindness unilateral
         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
    Cataract
         subjects affected / exposed
    24 / 4668 (0.51%)
    32 / 4672 (0.68%)
         occurrences causally related to treatment / all
    29 / 29
    35 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal erosion
         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
    Diabetic blindness
         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
    Diabetic retinal oedema
         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
    Diabetic retinopathy
         subjects affected / exposed
    9 / 4668 (0.19%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    9 / 9
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         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
    Eye 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
    Eyelid ptosis
         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
    Glaucoma
         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
    Iridocyclitis
         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
    Iritis
         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
    Macular fibrosis
         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
    0 / 0
    0 / 0
    Macular 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
    Macular rupture
         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
    Open angle glaucoma
         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
    Optic ischaemic neuropathy
         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
    Optic nerve infarction
         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
    Papilloedema
         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
    Retinal aneurysm
         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
    Retinal artery embolism
         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
    Retinal artery occlusion
         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
    Retinal degeneration
         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
    Retinal detachment
         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
    Retinal 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
    Retinal infarction
         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
    Retinal vascular occlusion
         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
    Retinal vein occlusion
         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
    Retinal vein 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
    Retinopathy
         subjects affected / exposed
    2 / 4668 (0.04%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy haemorrhagic
         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
    Retinopathy proliferative
         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
    Ulcerative keratitis
         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
    Vision blurred
         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
    Visual impairment
         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
    Vitreous adhesions
         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
    Vitreous haemorrhage
         subjects affected / exposed
    6 / 4668 (0.13%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    6 / 6
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         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
    Abdominal distension
         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
    Abdominal hernia
         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
    Abdominal incarcerated hernia
         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
    Abdominal 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
    Abdominal pain
         subjects affected / exposed
    20 / 4668 (0.43%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    20 / 20
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         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
    Abdominal pain upper
         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
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         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
    Acid peptic 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
    Acquired oesophageal web
         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
    Anal fistula
         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
    Anal skin tags
         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
    Ascites
         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
    Barrett's oesophagus
         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
    Cardiospasm
         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
    Change of bowel habit
         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 gastritis
         subjects affected / exposed
    0 / 4668 (0.00%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    9 / 4668 (0.19%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    9 / 9
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         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
    Colitis ulcerative
         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
    Colonic pseudo-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
    Constipation
         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
    0 / 0
    0 / 0
    Crohn's disease
         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
    Diarrhoea
         subjects affected / exposed
    14 / 4668 (0.30%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    14 / 14
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         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
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         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
    Diverticulum
         subjects affected / exposed
    2 / 4668 (0.04%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         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
    Diverticulum intestinal haemorrhagic
         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
    Duodenal perforation
         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
    Duodenal 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
    Duodenal ulcer
         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
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         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
    Duodenal ulcer perforation
         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
    Duodenitis
         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
    Dyspepsia
         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
    Dysphagia
         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
    Enteritis
         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
    Enterocolitis
         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
    Enterocutaneous fistula
         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
    Enterovesical fistula
         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
    Epigastric discomfort
         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
    Erosive oesophagitis
         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
    Faecal incontinence
         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
    Faecalith
         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
    Faecaloma
         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
    Food poisoning
         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 antral vascular ectasia
         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
    Gastric 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
    Gastric polyps
         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
    Gastric ulcer
         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
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         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
    Gastric ulcer 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
    Gastritis
         subjects affected / exposed
    15 / 4668 (0.32%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    16 / 16
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    4 / 4668 (0.09%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    4 / 4
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    2 / 4668 (0.04%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         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
    Gastrointestinal 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
    Gastrointestinal haemorrhage
         subjects affected / exposed
    14 / 4668 (0.30%)
    21 / 4672 (0.45%)
         occurrences causally related to treatment / all
    17 / 17
    27 / 27
         deaths causally related to treatment / all
    2 / 2
    3 / 3
    Gastrointestinal hypomotility
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         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
    Gastrointestinal polyp 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
    Gastrointestinal ulcer haemorrhage
         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
    Gastrooesophageal reflux disease
         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
    0 / 0
    0 / 0
    Haematemesis
         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
    Haematochezia
         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
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         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
    Haemorrhoids
         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
    Hiatus hernia
         subjects affected / exposed
    0 / 4668 (0.00%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         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
    0 / 0
    0 / 0
    Ileus paralytic
         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
    Impaired gastric emptying
         subjects affected / exposed
    5 / 4668 (0.11%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    6 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hiatus hernia
         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
    Incarcerated inguinal hernia
         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
    Incarcerated umbilical hernia
         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
    Inflammatory bowel 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
    Inguinal hernia
         subjects affected / exposed
    12 / 4668 (0.26%)
    14 / 4672 (0.30%)
         occurrences causally related to treatment / all
    15 / 15
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal infarction
         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
    Intestinal ischaemia
         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
    1 / 1
    Intestinal obstruction
         subjects affected / exposed
    2 / 4668 (0.04%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    2 / 2
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intestinal polyp
         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
    Irritable bowel syndrome
         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
    Large intestinal 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
    Large intestine 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
    Large intestine polyp
         subjects affected / exposed
    16 / 4668 (0.34%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    16 / 16
    18 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         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
    Mallory-Weiss syndrome
         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
    Mechanical ileus
         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
    Melaena
         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
    Mesenteric artery 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
    1 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    8 / 4668 (0.17%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    9 / 9
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         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
    Oedematous pancreatitis
         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 achalasia
         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 varices haemorrhage
         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
    Oesophagitis
         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
    Oesophagitis ulcerative
         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
    Pancreatic cyst
         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
    Pancreatic disorder
         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
    Pancreatic 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
    1 / 1
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    18 / 4668 (0.39%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    20 / 20
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pancreatitis acute
         subjects affected / exposed
    14 / 4668 (0.30%)
    19 / 4672 (0.41%)
         occurrences causally related to treatment / all
    14 / 14
    22 / 22
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pancreatitis chronic
         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
    Pancreatitis relapsing
         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
    Peptic ulcer
         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
    Peritoneal adhesions
         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
    Peritoneal 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
    Proctitis ulcerative
         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
    Reactive gastropathy
         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 haemorrhage
         subjects affected / exposed
    6 / 4668 (0.13%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    7 / 7
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         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
    Rectal prolapse
         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
    Reflux gastritis
         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
    Retroperitoneal haematoma
         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
    Retroperitoneal haemorrhage
         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
    Retroperitoneal 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
    Salivary gland 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
    Short-bowel 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
    Small intestinal obstruction
         subjects affected / exposed
    10 / 4668 (0.21%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    12 / 12
    23 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen tongue
         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
    Tooth socket 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
    Umbilical hernia
         subjects affected / exposed
    6 / 4668 (0.13%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    6 / 6
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    6 / 4668 (0.13%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    6 / 6
    8 / 8
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 4668 (0.02%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    8 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    17 / 4668 (0.36%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    20 / 20
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic elastosis
         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
    Actinic keratosis
         subjects affected / exposed
    4 / 4668 (0.09%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alopecia areata
         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
    Angioedema
         subjects affected / exposed
    6 / 4668 (0.13%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    8 / 8
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic pigmented purpura
         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 spontaneous urticaria
         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
    Decubitus ulcer
         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
    Dermatitis
         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
    Dermatitis contact
         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
    Diabetic foot
         subjects affected / exposed
    66 / 4668 (1.41%)
    80 / 4672 (1.71%)
         occurrences causally related to treatment / all
    88 / 88
    94 / 94
         deaths causally related to treatment / all
    0 / 0
    3 / 3
    Diabetic neuropathic ulcer
         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
    Diabetic ulcer
         subjects affected / exposed
    1 / 4668 (0.02%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    4 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         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
    Haemorrhage subcutaneous
         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
    Keloid scar
         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
    Lichen sclerosus
         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
    Lividity
         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
    Melanocytic hyperplasia
         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
    Nail bed 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
    Necrobiosis lipoidica diabeticorum
         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
    Neurodermatitis
         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
    Neuropathic ulcer
         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
    Parapsoriasis
         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
    Pemphigoid
         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
    Psoriasis
         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
    Skin lesion
         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
    Skin ulcer
         subjects affected / exposed
    10 / 4668 (0.21%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    10 / 10
    15 / 15
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Skin necrosis
         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
    Stasis dermatitis
         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
    Toxic epidermal necrolysis
         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
    Urticaria papular
         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 and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    108 / 4668 (2.31%)
    94 / 4672 (2.01%)
         occurrences causally related to treatment / all
    124 / 124
    105 / 105
         deaths causally related to treatment / all
    10 / 10
    8 / 8
    Acute prerenal failure
         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
    Azotaemia
         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
    0 / 0
    Bladder diverticulum
         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 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
    Bladder hypertrophy
         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
    Bladder neck obstruction
         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
    Bladder outlet obstruction
         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 prolapse
         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
    Bladder stenosis
         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
    Calculus 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
    Calculus ureteric
         subjects affected / exposed
    10 / 4668 (0.21%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    10 / 10
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         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
    Chronic kidney disease
         subjects affected / exposed
    52 / 4668 (1.11%)
    52 / 4672 (1.11%)
         occurrences causally related to treatment / all
    60 / 60
    55 / 55
         deaths causally related to treatment / all
    11 / 11
    8 / 8
    Diabetic nephropathy
         subjects affected / exposed
    6 / 4668 (0.13%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    7 / 7
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         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
    Fibrillary glomerulonephritis
         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
    Focal segmental glomerulosclerosis
         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
    Glomerulonephritis membranous
         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
    Glomerulosclerosis
         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
    Haematuria
         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
    1 / 1
    0 / 0
    Haemorrhage urinary tract
         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
    Hydronephrosis
         subjects affected / exposed
    5 / 4668 (0.11%)
    2 / 4672 (0.04%)
         occurrences causally related to treatment / all
    6 / 6
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesangioproliferative glomerulonephritis
         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
    Microalbuminuria
         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
    Nephritis
         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
    Nephrolithiasis
         subjects affected / exposed
    26 / 4668 (0.56%)
    21 / 4672 (0.45%)
         occurrences causally related to treatment / all
    27 / 27
    22 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    6 / 4668 (0.13%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    6 / 6
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Nephropathy toxic
         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
    Nephrotic syndrome
         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
    Nocturia
         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 uropathy
         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
    Pelvi-ureteric 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
    Polyuria
         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
    Proteinuria
         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
    Renal artery arteriosclerosis
         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 artery occlusion
         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 artery stenosis
         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
    Renal colic
         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
    Renal cyst
         subjects affected / exposed
    5 / 4668 (0.11%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    5 / 5
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    20 / 4668 (0.43%)
    31 / 4672 (0.66%)
         occurrences causally related to treatment / all
    21 / 21
    33 / 33
         deaths causally related to treatment / all
    4 / 4
    6 / 6
    Renal impairment
         subjects affected / exposed
    14 / 4668 (0.30%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    14 / 14
    10 / 10
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Renal haemorrhage
         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
    Renal infarct
         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 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
    Renal pain
         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 tubular necrosis
         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
    0 / 0
    0 / 0
    Single functional kidney
         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
    Stress urinary incontinence
         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
    Tubulointerstitial nephritis
         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
    Ureteral necrosis
         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
    Ureteral 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
    Ureteric 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
    Ureteric stenosis
         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
    Urethral stenosis
         subjects affected / exposed
    4 / 4668 (0.09%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    4 / 4
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         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
    Urinary incontinence
         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
    Urinary retention
         subjects affected / exposed
    8 / 4668 (0.17%)
    12 / 4672 (0.26%)
         occurrences causally related to treatment / all
    8 / 8
    13 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         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
    Endocrine disorders
    Autoimmune thyroiditis
         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
    Cushing's 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
    Goitre
         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
    Hypercorticoidism
         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
    Hyperparathyroidism primary
         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
    Hyperthyroidism
         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
    Hypoaldosteronism
         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
    Hypothyroidism
         subjects affected / exposed
    6 / 4668 (0.13%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid C-cell hyperplasia
         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
    Thyroiditis
         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
    Thyroiditis subacute
         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
    Toxic nodular goitre
         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
    Musculoskeletal and connective tissue disorders
    Acquired claw toe
         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
    Arthralgia
         subjects affected / exposed
    10 / 4668 (0.21%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    10 / 10
    14 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    16 / 4668 (0.34%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    17 / 17
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis reactive
         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
    Arthropathy
         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
    Back 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
    Back pain
         subjects affected / exposed
    14 / 4668 (0.30%)
    20 / 4672 (0.43%)
         occurrences causally related to treatment / all
    14 / 14
    21 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         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
    Cervical spinal stenosis
         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
    Compartment 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
    0 / 0
    Costochondritis
         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
    Diastasis recti abdominis
         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
    Dupuytren's contracture
         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
    Fibromyalgia
         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
    Foot deformity
         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
    Fracture nonunion
         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
    Gouty arthritis
         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
    Groin pain
         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
    Haemarthrosis
         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
    Intervertebral disc degeneration
         subjects affected / exposed
    4 / 4668 (0.09%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    4 / 4
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc 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
    Intervertebral disc displacement
         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
    Intervertebral disc protrusion
         subjects affected / exposed
    13 / 4668 (0.28%)
    23 / 4672 (0.49%)
         occurrences causally related to treatment / all
    14 / 14
    27 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint 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
    Lumbar spinal stenosis
         subjects affected / exposed
    11 / 4668 (0.24%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    12 / 12
    9 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscal degeneration
         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
    Mobility decreased
         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
    Muscle 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
    Muscle spasms
         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
    Muscular weakness
         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
    Musculoskeletal chest pain
         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
    0 / 0
    0 / 0
    Musculoskeletal pain
         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
    Myositis
         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
    Neck pain
         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
    Neuropathic arthropathy
         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
    Osteitis deformans
         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
    Osteoarthritis
         subjects affected / exposed
    75 / 4668 (1.61%)
    64 / 4672 (1.37%)
         occurrences causally related to treatment / all
    80 / 80
    69 / 69
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         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
    Osteolysis
         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
    Osteonecrosis
         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
    Osteoporotic 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
    Pain in extremity
         subjects affected / exposed
    7 / 4668 (0.15%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    7 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological 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
    Periarthritis
         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
    Polyarthritis
         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
    Polymyalgia rheumatica
         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
    Rhabdomyolysis
         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
    Rheumatoid arthritis
         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
    Rotator cuff syndrome
         subjects affected / exposed
    5 / 4668 (0.11%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    5 / 5
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
         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 column stenosis
         subjects affected / exposed
    7 / 4668 (0.15%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    7 / 7
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal instability
         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 osteoarthritis
         subjects affected / exposed
    9 / 4668 (0.19%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    9 / 9
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         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
    Spondylolisthesis
         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
    Synovial cyst
         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
    Synovitis
         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
    Tendonitis
         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
    Trigger finger
         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
    Ulnocarpal abutment 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
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         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
    Abdominal wall abscess
         subjects affected / exposed
    1 / 4668 (0.02%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    2 / 2
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         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
    Abscess limb
         subjects affected / exposed
    5 / 4668 (0.11%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         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
    Abscess of salivary gland
         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
    Acute hepatitis B
         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
    Acute sinusitis
         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
    Anal abscess
         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
    Appendicitis
         subjects affected / exposed
    8 / 4668 (0.17%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    8 / 8
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         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
    Arteriosclerotic gangrene
         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
    Arthritis bacterial
         subjects affected / exposed
    2 / 4668 (0.04%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         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
    Atypical pneumonia
         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
    Bacteraemia
         subjects affected / exposed
    5 / 4668 (0.11%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial food poisoning
         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
    Bacterial infection
         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
    Bacterial sepsis
         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
    Biliary sepsis
         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 tract infection
         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
    Breast abscess
         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
    Bronchiolitis
         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
    Bronchitis
         subjects affected / exposed
    15 / 4668 (0.32%)
    24 / 4672 (0.51%)
         occurrences causally related to treatment / all
    15 / 15
    25 / 25
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Bronchopneumonia
         subjects affected / exposed
    11 / 4668 (0.24%)
    19 / 4672 (0.41%)
         occurrences causally related to treatment / all
    13 / 13
    21 / 21
         deaths causally related to treatment / all
    2 / 2
    4 / 4
    Campylobacter gastroenteritis
         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
    Carbuncle
         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
    Cardiac valve abscess
         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
    Cellulitis
         subjects affected / exposed
    37 / 4668 (0.79%)
    54 / 4672 (1.16%)
         occurrences causally related to treatment / all
    50 / 50
    61 / 61
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Cellulitis gangrenous
         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
    Cellulitis of male external genital organ
         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
    Cervicitis
         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
    Cholecystitis infective
         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
    Cholera
         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
    Citrobacter sepsis
         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
    Clostridium colitis
         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
    Clostridium difficile colitis
         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
    Clostridium difficile infection
         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
    Cystitis
         subjects affected / exposed
    7 / 4668 (0.15%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    7 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryocystitis
         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
    Dengue fever
         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 related infection
         subjects affected / exposed
    5 / 4668 (0.11%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    5 / 5
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Device related sepsis
         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
    Diabetic foot infection
         subjects affected / exposed
    11 / 4668 (0.24%)
    9 / 4672 (0.19%)
         occurrences causally related to treatment / all
    12 / 12
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         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
    Diarrhoea infectious
         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
    Diverticulitis
         subjects affected / exposed
    7 / 4668 (0.15%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    8 / 8
    13 / 13
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Dysentery
         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
    Ear infection
         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
    Endocarditis
         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
    Endocarditis enterococcal
         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
    Endocarditis staphylococcal
         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
    Endophthalmitis
         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
    Enterobacter pneumonia
         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
    Enterococcal infection
         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
    Epididymitis
         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
    Epididymitis ureaplasmal
         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
    Erysipelas
         subjects affected / exposed
    10 / 4668 (0.21%)
    14 / 4672 (0.30%)
         occurrences causally related to treatment / all
    11 / 11
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         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
    Escherichia pyelonephritis
         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
    Escherichia urinary tract infection
         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
    Extradural abscess
         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
    Eye infection
         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 abscess
         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 empyema
         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
    Gangrene
         subjects affected / exposed
    10 / 4668 (0.21%)
    12 / 4672 (0.26%)
         occurrences causally related to treatment / all
    13 / 13
    14 / 14
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Gas gangrene
         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
    Gastritis bacterial
         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
    Gastroenteritis
         subjects affected / exposed
    33 / 4668 (0.71%)
    31 / 4672 (0.66%)
         occurrences causally related to treatment / all
    34 / 34
    31 / 31
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Gastroenteritis bacterial
         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
    Gastroenteritis norovirus
         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
    Gastroenteritis salmonella
         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
    Gastroenteritis viral
         subjects affected / exposed
    9 / 4668 (0.19%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    9 / 9
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         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
    Gingivitis
         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
    Groin abscess
         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
    Haematoma infection
         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
    Helicobacter gastritis
         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
    Helicobacter infection
         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
    Herpes virus infection
         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
    Herpes zoster
         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
    Human ehrlichiosis
         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
    Ileal gangrene
         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
    Incision site infection
         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
    Infected bites
         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
    Infected dermal 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
    Infection
         subjects affected / exposed
    2 / 4668 (0.04%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    2 / 2
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         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
    Infectious colitis
         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
    Infectious pleural effusion
         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
    Infective exacerbation of bronchiectasis
         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
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    2 / 4668 (0.04%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    4 / 4
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 4668 (0.06%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    3 / 3
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intervertebral discitis
         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
    Kidney infection
         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
    Klebsiella bacteraemia
         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
    Klebsiella sepsis
         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
    Laryngitis
         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
    Legionella infection
         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
    Liver abscess
         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
    Lobar pneumonia
         subjects affected / exposed
    15 / 4668 (0.32%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    16 / 16
    15 / 15
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Localised infection
         subjects affected / exposed
    7 / 4668 (0.15%)
    8 / 4672 (0.17%)
         occurrences causally related to treatment / all
    9 / 9
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lower respiratory tract infection
         subjects affected / exposed
    15 / 4668 (0.32%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    16 / 16
    15 / 15
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lung infection
         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
    1 / 1
    Mastitis
         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
    Mastoiditis
         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
    Mediastinitis
         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
    Meningitis
         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
    Meningitis pneumococcal
         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
    Metapneumovirus infection
         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
    Nasopharyngitis
         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
    Necrotising fasciitis
         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
    1 / 1
    0 / 0
    Neutropenic sepsis
         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
    Oesophageal candidiasis
         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
    Oral candidiasis
         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
    Orchitis
         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
    Osteomyelitis
         subjects affected / exposed
    21 / 4668 (0.45%)
    23 / 4672 (0.49%)
         occurrences causally related to treatment / all
    27 / 27
    30 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis 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
    Osteomyelitis chronic
         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
    Otitis externa
         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
    Otitis media
         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
    Otitis media chronic
         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
    Pancreas infection
         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
    Parainfluenzae virus infection
         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
    Parotitis
         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
    Penile infection
         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
    Perichondritis
         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
    Peritonitis
         subjects affected / exposed
    5 / 4668 (0.11%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    6 / 6
    9 / 9
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Peritonitis bacterial
         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
    1 / 1
    0 / 0
    Peritonsillar abscess
         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
    Pharyngitis
         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
    Pilonidal 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
    Plasmodium falciparum infection
         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
    Pneumococcal sepsis
         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
    Pneumonia
         subjects affected / exposed
    133 / 4668 (2.85%)
    141 / 4672 (3.02%)
         occurrences causally related to treatment / all
    154 / 154
    157 / 157
         deaths causally related to treatment / all
    20 / 20
    15 / 15
    Pneumonia bacterial
         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
    Pneumonia influenzal
         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 legionella
         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
    Pneumonia pneumococcal
         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
    Pneumonia pseudomonal
         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
    Pneumonia staphylococcal
         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
    Pneumonia viral
         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
    Post procedural cellulitis
         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
    Post procedural infection
         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
    Post procedural sepsis
         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
    Postoperative abscess
         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
    Postoperative wound infection
         subjects affected / exposed
    9 / 4668 (0.19%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    9 / 9
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic abscess
         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
    Pseudomembranous colitis
         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
    Psoas abscess
         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
    Pulmonary mycosis
         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
    Pulmonary sepsis
         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
    2 / 2
    1 / 1
    Pulmonary tuberculosis
         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
    Pyelonephritis
         subjects affected / exposed
    9 / 4668 (0.19%)
    10 / 4672 (0.21%)
         occurrences causally related to treatment / all
    9 / 9
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pyelonephritis acute
         subjects affected / exposed
    6 / 4668 (0.13%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    9 / 9
    6 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pyuria
         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
    Rectal abscess
         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 tract infection
         subjects affected / exposed
    2 / 4668 (0.04%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    2 / 2
    10 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         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 tract infection viral
         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
    Salmonella sepsis
         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
    Salmonellosis
         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
    Scrotal abscess
         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
    Sepsis
         subjects affected / exposed
    48 / 4668 (1.03%)
    34 / 4672 (0.73%)
         occurrences causally related to treatment / all
    50 / 50
    36 / 36
         deaths causally related to treatment / all
    13 / 13
    12 / 12
    Sepsis 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
    Septic shock
         subjects affected / exposed
    8 / 4668 (0.17%)
    13 / 4672 (0.28%)
         occurrences causally related to treatment / all
    9 / 9
    13 / 13
         deaths causally related to treatment / all
    6 / 6
    8 / 8
    Sinusitis
         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
    Soft tissue infection
         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
    Staphylococcal bacteraemia
         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
    Staphylococcal infection
         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
    1 / 1
    Staphylococcal sepsis
         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
    Staphylococcal skin infection
         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
    Streptococcal bacteraemia
         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
    Streptococcal infection
         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
    Subcutaneous abscess
         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
    Testicular abscess
         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
    Tonsillitis
         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
    Tooth abscess
         subjects affected / exposed
    0 / 4668 (0.00%)
    5 / 4672 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
         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
    Tracheitis
         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
    Tracheobronchitis
         subjects affected / exposed
    0 / 4668 (0.00%)
    3 / 4672 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Tuberculosis
         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
    Tuberculosis of genitourinary system
         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 respiratory tract infection
         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
    Urinary tract infection
         subjects affected / exposed
    47 / 4668 (1.01%)
    71 / 4672 (1.52%)
         occurrences causally related to treatment / all
    51 / 51
    79 / 79
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Urinary tract infection bacterial
         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
    Urosepsis
         subjects affected / exposed
    8 / 4668 (0.17%)
    17 / 4672 (0.36%)
         occurrences causally related to treatment / all
    8 / 8
    19 / 19
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Vaginal abscess
         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
    Vestibular neuronitis
         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
    Viral infection
         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
    Viral myocarditis
         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
    Viral pharyngitis
         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
    Viral sinusitis
         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
    Viral upper respiratory tract infection
         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
    Wound infection
         subjects affected / exposed
    6 / 4668 (0.13%)
    0 / 4672 (0.00%)
         occurrences causally related to treatment / all
    6 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         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
    Wound sepsis
         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
    Zygomycosis
         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
    Metabolism and nutrition disorders
    Cachexia
         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
    Cell death
         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
    Decreased appetite
         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
    Dehydration
         subjects affected / exposed
    30 / 4668 (0.64%)
    22 / 4672 (0.47%)
         occurrences causally related to treatment / all
    30 / 30
    22 / 22
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Diabetes mellitus
         subjects affected / exposed
    3 / 4668 (0.06%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    3 / 3
    12 / 12
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Diabetes mellitus inadequate control
         subjects affected / exposed
    25 / 4668 (0.54%)
    43 / 4672 (0.92%)
         occurrences causally related to treatment / all
    28 / 28
    47 / 47
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Diabetic complication
         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
    Diabetic ketoacidosis
         subjects affected / exposed
    11 / 4668 (0.24%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    12 / 12
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyslipidaemia
         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
    Electrolyte imbalance
         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
    Failure to thrive
         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
    1 / 1
    0 / 0
    Fluid overload
         subjects affected / exposed
    8 / 4668 (0.17%)
    4 / 4672 (0.09%)
         occurrences causally related to treatment / all
    8 / 8
    6 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Fluid retention
         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
    Gout
         subjects affected / exposed
    4 / 4668 (0.09%)
    6 / 4672 (0.13%)
         occurrences causally related to treatment / all
    8 / 8
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         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
    Hyperglycaemia
         subjects affected / exposed
    34 / 4668 (0.73%)
    49 / 4672 (1.05%)
         occurrences causally related to treatment / all
    35 / 35
    52 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    9 / 4668 (0.19%)
    15 / 4672 (0.32%)
         occurrences causally related to treatment / all
    10 / 10
    15 / 15
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hyperlipidaemia
         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
    Hyperosmolar hyperglycaemic state
         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
    Hypervolaemia
         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
    Hypocalcaemia
         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
    Hypoglycaemia
         subjects affected / exposed
    44 / 4668 (0.94%)
    75 / 4672 (1.61%)
         occurrences causally related to treatment / all
    60 / 60
    92 / 92
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    7 / 4668 (0.15%)
    7 / 4672 (0.15%)
         occurrences causally related to treatment / all
    8 / 8
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         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
    Hyponatraemia
         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
    0 / 0
    1 / 1
    Hypovolaemia
         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
    Insulin-requiring type 2 diabetes mellitus
         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
    Iron deficiency
         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
    Ketoacidosis
         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
    Lactic acidosis
         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
    Malnutrition
         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
    Metabolic acidosis
         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
    Metabolic 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
    Metabolic syndrome
         subjects affected / exposed
    0 / 4668 (0.00%)
    1 / 4672 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    8 / 4668 (0.17%)
    11 / 4672 (0.24%)
         occurrences causally related to treatment / all
    8 / 8
    11 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         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
    Vitamin B12 deficiency
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Liraglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    684 / 4668 (14.65%)
    210 / 4672 (4.49%)
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    266 / 4668 (5.70%)
    102 / 4672 (2.18%)
         occurrences all number
    355
    124
    Nausea
         subjects affected / exposed
    517 / 4668 (11.08%)
    129 / 4672 (2.76%)
         occurrences all number
    655
    149

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2011
    1) Changes to action in exclusion, randomisation and visit procedures in cases of measured calcitonin values ≥50 ng/L (changed from ≥100 ng/L). 2) Calcitonin values ≥20 ng/L reported as MESI during the trial. 3). Actions taken in case of suspicion of acute hypersensitivity or immune-complex disease.4) Actions taken in case a subject undergoes a thyroidectomy. Specification of history of concomitant cardiovascular disease. 5) Diabetic foot ulcer included in history of diabetes complication. 6) Definition of immediate and delayed hypersensitivity reaction. 7) Subject information updated accordingly.
    08 Jul 2011
    1) Subjects on premixed insulin was now considered eligible for participation in the trial. 2) Definition of diabetes-related blindness included
    17 May 2012
    1) Possible reintroduction of subjects violating exclusion criteria 2 and/or 3 to support retention. Subjects could be reintroduced to randomised treatment after a wash-out period. 2) Changes to the recording of concomitant medication during hospitalisation. 3) Introduction of ‘male partner-consent’ in case of a pregnancy
    11 Apr 2013
    1) Inclusion criteria 3 updated: Subjects randomised in error due to not meeting the age criterion at screening could be reintroduced on originally randomised treatment as each subject reaches the required age. 2) Updates to the adverse event section and event adjudication process. 3) Liraglutide background section updated based on the Investigator’s Brochure. 4) An additional SI/IC form to ensure collection of information on primary outcome
    20 Jun 2014
    1) Introducing a staggered close down of sites. 2) Follow-up visit (visit 16) applicable for all randomised subjects. 3) Revision of the statistical considerations to meet regulatory expectations and to align with the Statistical Programming Plan

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27295427
    http://www.ncbi.nlm.nih.gov/pubmed/26855018
    http://www.ncbi.nlm.nih.gov/pubmed/26864124
    http://www.ncbi.nlm.nih.gov/pubmed/27320184
    http://www.ncbi.nlm.nih.gov/pubmed/27274772
    http://www.ncbi.nlm.nih.gov/pubmed/25275271
    http://www.ncbi.nlm.nih.gov/pubmed/24176437
    http://www.ncbi.nlm.nih.gov/pubmed/25656058
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