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    Clinical Trial Results:
    SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity

    Summary
    EudraCT number
    		 2017-003380-35
    Trial protocol
    		 BG   DK   FI   IE   PT   GB   LV   NL   CZ   HU   BE   AT   SE   HR   NO   IT   RO  
    Global end of trial date
    29 Jun 2023

    Results information
    Results version number
    		 v1
    This version publication date
    11 Jul 2024
    First version publication date
    11 Jul 2024
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    EX9536-4388
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03574597
    WHO universal trial number (UTN)
    		 U1111-1200-5564
    Sponsors
    Sponsor organisation name
    Novo Nordisk A/S
    Sponsor organisation address
    Novo Alle, Bagsvaerd, Denmark, 2880
    Public contact
    Clinical Reporting Office (2834), Novo Nordisk A/S, clinicaltrials@novonordisk.com
    Scientific contact
    Clinical Reporting Office (2834), 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
    18 Jul 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that semaglutide subcutaneously 2.4 milligram (mg) once-weekly lowers the incidence of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in subjects with established cardiovascular (CV) disease and overweight or obesity.
    Protection of trial subjects
    This trial was conducted in accordance with the principles of the Declaration of Helsinki, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice, including the archiving of essential documents, and US Food and Drug Administration (FDA) 21 US Code of Federal Regulations (CFR) 312.50 and 312.56.
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2018
    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: 327
    Country: Number of subjects enrolled
    Austria: 120
    Country: Number of subjects enrolled
    Argentina: 359
    Country: Number of subjects enrolled
    Belgium: 128
    Country: Number of subjects enrolled
    Bulgaria: 356
    Country: Number of subjects enrolled
    Brazil: 606
    Country: Number of subjects enrolled
    Canada: 749
    Country: Number of subjects enrolled
    Colombia: 187
    Country: Number of subjects enrolled
    Czechia: 344
    Country: Number of subjects enrolled
    Germany: 885
    Country: Number of subjects enrolled
    Denmark: 198
    Country: Number of subjects enrolled
    Algeria: 47
    Country: Number of subjects enrolled
    Spain: 186
    Country: Number of subjects enrolled
    Finland: 168
    Country: Number of subjects enrolled
    France: 169
    Country: Number of subjects enrolled
    United Kingdom: 933
    Country: Number of subjects enrolled
    Greece: 354
    Country: Number of subjects enrolled
    Croatia: 141
    Country: Number of subjects enrolled
    Hungary: 135
    Country: Number of subjects enrolled
    India: 492
    Country: Number of subjects enrolled
    Ireland: 71
    Country: Number of subjects enrolled
    Israel: 310
    Country: Number of subjects enrolled
    Italy: 293
    Country: Number of subjects enrolled
    Japan: 357
    Country: Number of subjects enrolled
    Latvia: 177
    Country: Number of subjects enrolled
    Mexico: 341
    Country: Number of subjects enrolled
    Malaysia: 187
    Country: Number of subjects enrolled
    Netherlands: 342
    Country: Number of subjects enrolled
    Norway: 227
    Country: Number of subjects enrolled
    Poland: 640
    Country: Number of subjects enrolled
    Portugal: 137
    Country: Number of subjects enrolled
    Romania: 321
    Country: Number of subjects enrolled
    Russian Federation: 1491
    Country: Number of subjects enrolled
    Serbia: 184
    Country: Number of subjects enrolled
    Sweden: 183
    Country: Number of subjects enrolled
    Thailand: 156
    Country: Number of subjects enrolled
    Türkiye: 217
    Country: Number of subjects enrolled
    Taiwan: 155
    Country: Number of subjects enrolled
    Ukraine: 482
    Country: Number of subjects enrolled
    United States: 3652
    Country: Number of subjects enrolled
    South Africa: 797
    Worldwide total number of subjects
    17604
    EEA total number of subjects
    5575
    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)
    10876
    From 65 to 84 years
    6680
    85 years and over
    48

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were screened at 811 sites in 41 countries. Out of 811 sites, subjects were randomised at 804 sites.

    Pre-assignment
    Screening details
    		 Subjects were randomized in a 1:1 ratio to receive treatment with either semaglutide or placebo as an adjunct to standard-of-care. The trial had 247 weeks treatment period (16 weeks of dose escalation period and 231 weeks of maintenance dose) followed by a 5-week follow-up period.

    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
    Blinding implementation details
    The trial products containing the active drug (semaglutide) and the placebo drug were visually identical and packed in a manner that maintained blinding.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Semaglutide
    Arm description
    		 Subjects received semaglutide subcutaneously once weekly in a dose escalation manner with dose increases every 4 weeks for up to week 16 (0.25 mg [week 0 - week 4], 0.5 mg [week 4 - week 8], 1.0 mg [week 8 - week 12] and 1.7 mg [week 12 - week 16]) followed by maintenance dose of 2.4 mg received subcutaneously once weekly from week 16 up to week 247.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide B 3.0 milligram per milliliter (mg/mL)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received semaglutide injection once weekly at the same day of the week. Injections were to be administered by subcutaneous injection in the thigh, abdomen or upper arm at any time of day irrespective of meals.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received placebo (matched to semaglutide) subcutaneously once weekly up to week 247.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Semaglutide placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received semaglutide injection once weekly at the same day of the week. Injections were to be administered by subcutaneous injection in the thigh, abdomen or upper arm at any time of day irrespective of meals.

    Number of subjects in period 1
    		Semaglutide Placebo
    Started
    8803
    8801
    Full analysis set (FAS)
    8803
    8801
    Completed
    8544
    8517
    Not completed
    259
    284
         Consent withdrawn by subject
    67
    96
         Lost to follow-up
    192
    188

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Semaglutide
    Reporting group description
    		 Subjects received semaglutide subcutaneously once weekly in a dose escalation manner with dose increases every 4 weeks for up to week 16 (0.25 mg [week 0 - week 4], 0.5 mg [week 4 - week 8], 1.0 mg [week 8 - week 12] and 1.7 mg [week 12 - week 16]) followed by maintenance dose of 2.4 mg received subcutaneously once weekly from week 16 up to week 247.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (matched to semaglutide) subcutaneously once weekly up to week 247.

    Reporting group values
    		 Semaglutide Placebo Total
    Number of subjects
    		 8803 8801 17604
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 61.6 ( 8.9 ) 61.6 ( 8.8 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 2448 2424 4872
        Male
    		 6355 6377 12732

    End points

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    End points reporting groups
    Reporting group title
    Semaglutide
    Reporting group description
    		 Subjects received semaglutide subcutaneously once weekly in a dose escalation manner with dose increases every 4 weeks for up to week 16 (0.25 mg [week 0 - week 4], 0.5 mg [week 4 - week 8], 1.0 mg [week 8 - week 12] and 1.7 mg [week 12 - week 16]) followed by maintenance dose of 2.4 mg received subcutaneously once weekly from week 16 up to week 247.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (matched to semaglutide) subcutaneously once weekly up to week 247.

    Primary: Time from randomisation to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke

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    End point title
    		 Time from randomisation to first occurrence of a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke
    End point description
    Number of subjects with first occurrence of endpoint consisted of CV death (undetermined cause of death presumed CV death), non-fatal MI, or non-fatal stroke are presented. The endpoint was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when subject withdrew consent, date of last contact with subject for subjects who were lost to follow-up (subject did not complete the trial and did not withdraw consent), date of death. FAS included all randomised subjects. All subjects were analysed according to the treatment to which they were assigned at randomisation.
    End point type
    Primary
    End point timeframe
    From randomisation to first occurrence of a composite endpoint
    End point values
    		 Semaglutide Placebo
    Number of subjects analysed
    8803
    8801
    Units: Subjects
    569
    701
    Statistical analysis title
    		 Semaglutide vs Placebo
    Statistical analysis description
    Data from the in-trial period. The endpoint was analysed using a Cox proportional hazards model with treatment as categorical fixed factor. Subjects without events of interest were censored at the end of their in-trial period.
    Comparison groups
    Semaglutide v Placebo
    Number of subjects included in analysis
    17604
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.89

    Secondary: Time from randomisation to first occurrence of a composite heart failure (HF) endpoint consisting of: HF hospitalisation, urgent HF visit or CV death

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    End point title
    		 Time from randomisation to first occurrence of a composite heart failure (HF) endpoint consisting of: HF hospitalisation, urgent HF visit or CV death
    End point description
    Number of subjects with first occurrence of a composite HF endpoint consisted of HF hospitalisation, urgent HF visit or CV death are presented. The endpoint was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when subject withdrew consent, date of last contact with subject for subjects who were lost to follow-up (subject did not compete the trial and did not withraw consent), date of death. FAS included all randomised. All subjects were analysed according to the treatment to which they were assigned at randomisation.
    End point type
    Secondary
    End point timeframe
    From randomisation to first occurrence of a composite endpoint
    End point values
    		 Semaglutide Placebo
    Number of subjects analysed
    8803
    8801
    Units: Subjects
    300
    361
    No statistical analyses for this end point

    Secondary: Time from randomisation to all-cause death

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    End point title
    		 Time from randomisation to all-cause death
    End point description
    Number of subjects with all-cause death are presented. The endpoint was evaluated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when subject withdrew consent, date of last contact with subject for subjects who were lost to follow-up (subject did not complete the trial and did not withdraw consent), date of death. FAS included all randomised subjects. All subjects were analysed according to the treatment to which they were assigned at randomisation.
    End point type
    Secondary
    End point timeframe
    Time from randomisation to event
    End point values
    		 Semaglutide Placebo
    Number of subjects analysed
    8803
    8801
    Units: Subjects
    375
    458
    No statistical analyses for this end point

    Secondary: Time from randomisation to CV death

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    End point title
    		 Time from randomisation to CV death
    End point description
    Number of subjects with CV death are presented. The endpoint was evalulated based on data from in-trial observation period. In-trial observation period defined as the period from date of randomisation to one of the following dates, whichever comes first: date of follow-up visit, date when subject withdrew consent, date of last contact with subject for subjects who were lost to follow-up (subject did not complete the trial and did not withdraw consent), date of death. FAS included all randomised subjects. All subjects were analysed according to the treatment to which they were assigned at randomisation.
    End point type
    Secondary
    End point timeframe
    Time from randomisation to event
    End point values
    		 Semaglutide Placebo
    Number of subjects analysed
    8803
    8801
    Units: Subjects
    223
    262
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomisation (week 0) up to end of follow-up visit (week 252)
    Adverse event reporting additional description
    AEs are reported based on data from in-trial observation period. Not all the AEs were collected systematically.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    Reporting groups
    Reporting group title
    Semaglutide
    Reporting group description
    		 Subjects received semaglutide subcutaneously once weekly in a dose escalation manner for up to week 16: 0.24 mg from week 0 to week 4, 0.5 mg from week 4 to week 8, 1.0 mg from week 8 to week 12, 1.7 mg from week 12 to week 16 and 2.4 mg from week 16 up to week 247 during the maintenance period followed by a 5-week follow-up period.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received placebo (matched to semaglutide) subcutaneously once weekly during dose escalation and maintenance periods up to week 247 followed by a 5-week follow-up period.

    Serious adverse events
    		 Semaglutide Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2941 / 8803 (33.41%)
    3204 / 8801 (36.40%)
         number of deaths (all causes)
    371
    460
         number of deaths resulting from adverse events
    19
    16
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic neuroma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Adenocarcinoma gastric
         subjects affected / exposed
    6 / 8803 (0.07%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    2 / 6
    1 / 5
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    Acute myeloid leukaemia
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute lymphocytic leukaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    15 / 8803 (0.17%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    3 / 16
    3 / 15
         deaths causally related to treatment / all
    0 / 2
    1 / 2
    Adenocarcinoma pancreas
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Adrenocortical carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of salivary gland
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign duodenal neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign mediastinal neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of cervix uteri
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of skin
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    18 / 8803 (0.20%)
    27 / 8801 (0.31%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder adenocarcinoma stage unspecified
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    3 / 8803 (0.03%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder papilloma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    10 / 8803 (0.11%)
    17 / 8801 (0.19%)
         occurrences causally related to treatment / all
    0 / 10
    2 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Bowen's disease
         subjects affected / exposed
    6 / 8803 (0.07%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 17
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    2 / 8803 (0.02%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage IV
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carcinoid tumour
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Cervix carcinoma stage II
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroid melanoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    6 / 8803 (0.07%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia stage 1
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    9 / 8803 (0.10%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer stage III
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenoma
         subjects affected / exposed
    11 / 8803 (0.12%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon cancer metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diffuse large B-cell lymphoma stage I
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma stage III
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endometrial adenocarcinoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential thrombocythaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epithelioid mesothelioma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid seborrhoeic keratosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer stage I
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal adenocarcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal cancer metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioblastoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemangioma
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head and neck cancer metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hormone receptor positive breast cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    9 / 8803 (0.10%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Hodgkin's disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hormone receptor positive HER2 negative breast cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypopharyngeal cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive papillary breast carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    8 / 8803 (0.09%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    2 / 8
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large cell lung cancer metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Large intestine benign neoplasm
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lipoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma recurrent
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    10 / 8803 (0.11%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 8
         deaths causally related to treatment / all
    0 / 2
    1 / 1
    Lung adenocarcinoma recurrent
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage I
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Lung carcinoma cell type unspecified stage II
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung neoplasm
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    5 / 8803 (0.06%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lymphoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    10 / 8803 (0.11%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    5 / 8803 (0.06%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm of uterine adnexa
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mantle cell lymphoma stage III
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanoma recurrent
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to bone
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    Metastases to liver
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 2
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Metastases to lung
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to spine
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic malignant melanoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastatic salivary gland cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic uterine cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to soft tissue
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngeal cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine breast tumour
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine carcinoma of prostate
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuroendocrine tumour of the lung
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour of the lung metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Oesophageal adenocarcinoma recurrent
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal adenocarcinoma stage IV
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral papilloma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian epithelial cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian granulosa cell tumour
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 5
         deaths causally related to treatment / all
    2 / 2
    2 / 5
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    3 / 8803 (0.03%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile squamous cell carcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Philadelphia positive chronic myeloid leukaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phyllodes tumour
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    5 / 8803 (0.06%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    5 / 8803 (0.06%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    60 / 8803 (0.68%)
    54 / 8801 (0.61%)
         occurrences causally related to treatment / all
    0 / 60
    1 / 54
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer stage I
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary myelofibrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    4 / 8803 (0.05%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    4 / 8803 (0.05%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer stage IV
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seminoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sebaceous carcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinonasal papilloma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin squamous cell carcinoma recurrent
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    6 / 8803 (0.07%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    1 / 4
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Small intestine carcinoma metastatic
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Soft tissue sarcoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer recurrent
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamoproliferative lesion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    5 / 8803 (0.06%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of head and neck
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    5 / 8803 (0.06%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Squamous cell carcinoma of skin
         subjects affected / exposed
    11 / 8803 (0.12%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Testicular cancer metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of renal pelvis and ureter metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter localised
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (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
    10 / 8803 (0.11%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Tracheal cancer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Waldenstrom's macroglobulinaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acrochordon
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of prostate
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carcinoid tumour of the gastrointestinal tract
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thymus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage II
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival neoplasm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemangioma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage III
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma recurrent
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oncologic complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary serous endometrial carcinoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine neuroendocrine tumour
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spindle cell sarcoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial spreading melanoma stage I
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm thrombosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    18 / 8803 (0.20%)
    17 / 8801 (0.19%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm rupture
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Aortic occlusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    6 / 8803 (0.07%)
    19 / 8801 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aorto-atrial fistula
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteriovenous fistula
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Behcet's syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding varicose vein
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure fluctuation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Deep vein thrombosis
         subjects affected / exposed
    13 / 8803 (0.15%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dry gangrene
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery embolism
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giant cell arteritis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    27 / 8803 (0.31%)
    24 / 8801 (0.27%)
         occurrences causally related to treatment / all
    0 / 30
    1 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    4 / 8803 (0.05%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    5 / 8803 (0.06%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypotension
         subjects affected / exposed
    23 / 8803 (0.26%)
    25 / 8801 (0.28%)
         occurrences causally related to treatment / all
    2 / 24
    1 / 30
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Iliac artery disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    6 / 8803 (0.07%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inferior vena cava stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macroangiopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    15 / 8803 (0.17%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating aortic ulcer
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    37 / 8803 (0.42%)
    45 / 8801 (0.51%)
         occurrences causally related to treatment / all
    1 / 41
    0 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    9 / 8803 (0.10%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    6 / 8803 (0.07%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    8 / 8803 (0.09%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    4 / 8803 (0.05%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    4 / 8803 (0.05%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Popliteal artery entrapment syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    7 / 8803 (0.08%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    1 / 3
    0 / 2
    Shock haemorrhagic
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subclavian artery occlusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Takayasu's arteritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular occlusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Angioplasty
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stent insertion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial septal defect repair
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary angioplasty
         subjects affected / exposed
    48 / 8803 (0.55%)
    64 / 8801 (0.73%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 68
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    245 / 8803 (2.78%)
    279 / 8801 (3.17%)
         occurrences causally related to treatment / all
    3 / 270
    3 / 343
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery bypass
         subjects affected / exposed
    69 / 8803 (0.78%)
    79 / 8801 (0.90%)
         occurrences causally related to treatment / all
    0 / 69
    1 / 79
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary revascularisation
         subjects affected / exposed
    23 / 8803 (0.26%)
    37 / 8801 (0.42%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 38
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-cerebral aneurysm operation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposuction
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    70 / 8803 (0.80%)
    114 / 8801 (1.30%)
         occurrences causally related to treatment / all
    2 / 81
    5 / 124
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sequestrectomy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleeve gastrectomy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent placement
         subjects affected / exposed
    10 / 8803 (0.11%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast reconstruction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthenia
         subjects affected / exposed
    10 / 8803 (0.11%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Catheter site haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    44 / 8803 (0.50%)
    47 / 8801 (0.53%)
         occurrences causally related to treatment / all
    3 / 45
    3 / 48
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    4 / 8803 (0.05%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    55 / 8803 (0.62%)
    57 / 8801 (0.65%)
         occurrences causally related to treatment / all
    4 / 55
    1 / 57
         deaths causally related to treatment / all
    4 / 55
    1 / 57
    Device related thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Discomfort
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocution
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fat necrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Feeling cold
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hanging
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hernia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Impaired healing
         subjects affected / exposed
    6 / 8803 (0.07%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site haematoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site ulcer
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 8803 (0.03%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 10
    Non-cardiac chest pain
         subjects affected / exposed
    88 / 8803 (1.00%)
    103 / 8801 (1.17%)
         occurrences causally related to treatment / all
    2 / 96
    7 / 112
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 8803 (0.01%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic cardiac valve stenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    5 / 8803 (0.06%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensation of foreign body
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    8 / 8803 (0.09%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 8
    0 / 12
    Sudden death
         subjects affected / exposed
    5 / 8803 (0.06%)
    16 / 8801 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 16
         deaths causally related to treatment / all
    0 / 5
    1 / 16
    Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tissue infiltration
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Treatment noncompliance
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device occlusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    22 / 8803 (0.25%)
    21 / 8801 (0.24%)
         occurrences causally related to treatment / all
    0 / 22
    1 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    2 / 8803 (0.02%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised oedema
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyloidosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media allergy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart transplant rejection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary immunodeficiency
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Abnormal uterine bleeding
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adnexa uteri cyst
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    34 / 8803 (0.39%)
    21 / 8801 (0.24%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast fibrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast oedema
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysmenorrhoea
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymal disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heavy menstrual bleeding
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrometra
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic organ prolapse
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    5 / 8803 (0.06%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal cyst
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spermatic cord disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal pain
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    28 / 8803 (0.32%)
    46 / 8801 (0.52%)
         occurrences causally related to treatment / all
    0 / 30
    1 / 51
         deaths causally related to treatment / all
    0 / 8
    0 / 15
    Acute respiratory distress syndrome
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Acute pulmonary oedema
         subjects affected / exposed
    5 / 8803 (0.06%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    5 / 8803 (0.06%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    32 / 8803 (0.36%)
    50 / 8801 (0.57%)
         occurrences causally related to treatment / all
    0 / 43
    1 / 63
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Cough
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dysphonia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    19 / 8803 (0.22%)
    35 / 8801 (0.40%)
         occurrences causally related to treatment / all
    1 / 20
    0 / 36
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 8803 (0.01%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Emphysema
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epiglottic cyst
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    9 / 8803 (0.10%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hydrothorax
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity pneumonitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Idiopathic interstitial pneumonia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune-mediated lung disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Lung consolidation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngeal polyp
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Painful respiration
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    12 / 8803 (0.14%)
    16 / 8801 (0.18%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pleurisy
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis aspiration
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pneumothorax
         subjects affected / exposed
    6 / 8803 (0.07%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    38 / 8803 (0.43%)
    43 / 8801 (0.49%)
         occurrences causally related to treatment / all
    4 / 39
    2 / 44
         deaths causally related to treatment / all
    0 / 8
    2 / 8
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pulmonary haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    4 / 8803 (0.05%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary microemboli
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    8 / 8803 (0.09%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pulmonary hypertension
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Respiratory disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    10 / 8803 (0.11%)
    16 / 8801 (0.18%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 16
         deaths causally related to treatment / all
    0 / 6
    0 / 9
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snoring
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stridor
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic sclerosis pulmonary
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal compression
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheomalacia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord thickening
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary granuloma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Alcohol use disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    6 / 8803 (0.07%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    4 / 8803 (0.05%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    5 / 8803 (0.06%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Conversion disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    13 / 8803 (0.15%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dissociative amnesia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dissociative identity disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal somatic symptom disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    2 / 8803 (0.02%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    4 / 8803 (0.05%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Mixed anxiety and depressive disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-induced psychotic disorder
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bipolar I disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catatonia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Personality change
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Withdrawal catatonia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    3 / 8803 (0.03%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device loosening
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lead dislodgement
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic cardiac valve malfunction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    16 / 8803 (0.18%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    7 / 16
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Biliary colic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis migration
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    44 / 8803 (0.50%)
    31 / 8801 (0.35%)
         occurrences causally related to treatment / all
    17 / 46
    12 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    10 / 8803 (0.11%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    3 / 10
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    27 / 8803 (0.31%)
    30 / 8801 (0.34%)
         occurrences causally related to treatment / all
    13 / 27
    17 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    13 / 8803 (0.15%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    3 / 13
    6 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholangitis acute
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholangitis
         subjects affected / exposed
    6 / 8803 (0.07%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    1 / 6
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drug-induced liver injury
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cholesterolosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder necrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic fibrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis alcoholic
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatorenal syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic function abnormal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperplastic cholecystopathy
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Liver disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertensive biliopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portosplenomesenteric venous thrombosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post cholecystectomy syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sphincter of Oddi dysfunction
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected drug-induced liver injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptogenic cirrhosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Amylase increased
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood calcitonin increased
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood osmolarity decreased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body temperature decreased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body temperature increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulation time shortened
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Culture positive
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment abnormal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise electrocardiogram abnormal
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    False positive investigation result
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric pH decreased
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme abnormal
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult blood positive
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic enzymes increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 test positive
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin abnormal
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine analysis abnormal
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anti-thyroid antibody positive
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body mass index increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial necrosis marker increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Accident at home
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Accident at work
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Accidental overdose
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 2
    1 / 1
    Anaemia postoperative
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    5 / 8803 (0.06%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anterior cord syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic pseudoaneurysm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cartilage injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 8803 (0.05%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery reocclusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary bypass stenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft occlusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft stenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis radiation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    6 / 8803 (0.07%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Crush injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis postoperative
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    51 / 8803 (0.58%)
    35 / 8801 (0.40%)
         occurrences causally related to treatment / all
    1 / 55
    0 / 39
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Extraskeletal ossification
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    11 / 8803 (0.12%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Femur fracture
         subjects affected / exposed
    13 / 8803 (0.15%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    5 / 8803 (0.06%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in respiratory tract
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal organ contusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal procedural complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroparesis postoperative
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    8 / 8803 (0.09%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 10
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Heat exhaustion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat illness
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    11 / 8803 (0.12%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    7 / 8803 (0.08%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunisation reaction
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    6 / 8803 (0.07%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    7 / 8803 (0.08%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    6 / 8803 (0.07%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    5 / 8803 (0.06%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lisfranc fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral plexus injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Maisonneuve fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    8 / 8803 (0.09%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes postoperative
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Nerve injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open globe injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    8 / 8803 (0.09%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial reocclusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fever
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    12 / 8803 (0.14%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural inflammation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural pulmonary embolism
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural stroke
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpericardiotomy syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative renal failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative respiratory distress
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    4 / 8803 (0.05%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    15 / 8803 (0.17%)
    21 / 8801 (0.24%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    11 / 8803 (0.12%)
    17 / 8801 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 17
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Scapula fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatic nerve injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder fracture
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    10 / 8803 (0.11%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    8 / 8803 (0.09%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma obstruction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    16 / 8803 (0.18%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural haemorrhage
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    5 / 8803 (0.06%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial rupture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    5 / 8803 (0.06%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    2 / 8803 (0.02%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic arthrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic heart injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic pancreatitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic arthritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar nerve injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site pseudoaneurysm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular graft thrombosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft stenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft restenosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    7 / 8803 (0.08%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    3 / 8803 (0.03%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary procedural complication
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reactive gastropathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma complication
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicuspid aortic valve
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CADASIL
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Factor II mutation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal arteriovenous malformation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odontogenic cyst
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patent ductus arteriosus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type IIa hyperlipidaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gilbert's syndrome
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitello-intestinal duct remnant
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    22 / 8803 (0.25%)
    18 / 8801 (0.20%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Acute myocardial infarction
         subjects affected / exposed
    209 / 8803 (2.37%)
    293 / 8801 (3.33%)
         occurrences causally related to treatment / all
    6 / 220
    9 / 324
         deaths causally related to treatment / all
    0 / 20
    0 / 22
    Acute left ventricular failure
         subjects affected / exposed
    6 / 8803 (0.07%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Angina pectoris
         subjects affected / exposed
    116 / 8803 (1.32%)
    150 / 8801 (1.70%)
         occurrences causally related to treatment / all
    2 / 126
    3 / 176
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    182 / 8803 (2.07%)
    209 / 8801 (2.37%)
         occurrences causally related to treatment / all
    5 / 205
    7 / 242
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anginal equivalent
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    3 / 8803 (0.03%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    7 / 8803 (0.08%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    7 / 8803 (0.08%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmic storm
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    7 / 8803 (0.08%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Atrial tachycardia
         subjects affected / exposed
    2 / 8803 (0.02%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    127 / 8803 (1.44%)
    152 / 8801 (1.73%)
         occurrences causally related to treatment / all
    7 / 139
    4 / 181
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Atrial flutter
         subjects affected / exposed
    23 / 8803 (0.26%)
    22 / 8801 (0.25%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    7 / 8803 (0.08%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    4 / 8803 (0.05%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    9 / 8803 (0.10%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bundle branch block left
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block right
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         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 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    26 / 8803 (0.30%)
    33 / 8801 (0.37%)
         occurrences causally related to treatment / all
    3 / 26
    0 / 33
         deaths causally related to treatment / all
    2 / 18
    0 / 26
    Cardiac failure
         subjects affected / exposed
    88 / 8803 (1.00%)
    113 / 8801 (1.28%)
         occurrences causally related to treatment / all
    4 / 114
    1 / 127
         deaths causally related to treatment / all
    0 / 15
    0 / 17
    Cardiopulmonary failure
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Cardiac failure chronic
         subjects affected / exposed
    23 / 8803 (0.26%)
    28 / 8801 (0.32%)
         occurrences causally related to treatment / all
    0 / 24
    1 / 29
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Cardiac failure congestive
         subjects affected / exposed
    31 / 8803 (0.35%)
    36 / 8801 (0.41%)
         occurrences causally related to treatment / all
    2 / 37
    2 / 51
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Cardiac perforation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac perfusion defect
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac valve disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    11 / 8803 (0.12%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 11
    0 / 8
    Cardiogenic shock
         subjects affected / exposed
    6 / 8803 (0.07%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Cardiomyopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Cardiac failure acute
         subjects affected / exposed
    32 / 8803 (0.36%)
    44 / 8801 (0.50%)
         occurrences causally related to treatment / all
    2 / 46
    0 / 50
         deaths causally related to treatment / all
    0 / 2
    0 / 6
    Chronic coronary syndrome
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    79 / 8803 (0.90%)
    106 / 8801 (1.20%)
         occurrences causally related to treatment / all
    2 / 80
    1 / 113
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Cor pulmonale
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    11 / 8803 (0.12%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    44 / 8803 (0.50%)
    53 / 8801 (0.60%)
         occurrences causally related to treatment / all
    2 / 49
    1 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery thrombosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary ostial stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diastolic dysfunction
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dilated cardiomyopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Intracardiac thrombus
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    9 / 8803 (0.10%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 8803 (0.01%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Left ventricular failure
         subjects affected / exposed
    4 / 8803 (0.05%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 6
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    Mitral valve stenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 8803 (0.01%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microvascular coronary artery disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    35 / 8803 (0.40%)
    31 / 8801 (0.35%)
         occurrences causally related to treatment / all
    0 / 36
    1 / 32
         deaths causally related to treatment / all
    0 / 15
    1 / 11
    Myocardial injury
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    21 / 8803 (0.24%)
    31 / 8801 (0.35%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 31
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Myocarditis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopericarditis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    3 / 8803 (0.03%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    5 / 8803 (0.06%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    3 / 8803 (0.03%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    3 / 8803 (0.03%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    7 / 8803 (0.08%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    18 / 8803 (0.20%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    2 / 19
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    4 / 8803 (0.05%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Ventricular tachycardia
         subjects affected / exposed
    36 / 8803 (0.41%)
    38 / 8801 (0.43%)
         occurrences causally related to treatment / all
    0 / 36
    1 / 49
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Ventricular tachyarrhythmia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    7 / 8803 (0.08%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Ventricular extrasystoles
         subjects affected / exposed
    12 / 8803 (0.14%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease mixed
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bifascicular block
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chordae tendinae rupture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic mitral regurgitation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinus arrest
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia induced cardiomyopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular dysfunction
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 8803 (0.01%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aphasia
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia stroke
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar artery aneurysm
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Basilar artery occlusion
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Brain oedema
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Brain stem infarction
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid arterial embolus
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery thrombosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    22 / 8803 (0.25%)
    24 / 8801 (0.27%)
         occurrences causally related to treatment / all
    0 / 23
    1 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    17 / 8803 (0.19%)
    23 / 8801 (0.26%)
         occurrences causally related to treatment / all
    1 / 18
    1 / 25
         deaths causally related to treatment / all
    1 / 2
    0 / 2
    Cerebral haemorrhage
         subjects affected / exposed
    7 / 8803 (0.08%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Cerebral haematoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral circulatory failure
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar ischaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    3 / 8803 (0.03%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Central pain syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system vasculitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system inflammation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    8 / 8803 (0.09%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebrovascular accident
         subjects affected / exposed
    35 / 8803 (0.40%)
    48 / 8801 (0.55%)
         occurrences causally related to treatment / all
    1 / 36
    3 / 50
         deaths causally related to treatment / all
    0 / 8
    1 / 12
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Conus medullaris syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corticobasal degeneration
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cranial nerve disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia with Lewy bodies
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelinating polyneuropathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplegia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    10 / 8803 (0.11%)
    14 / 8801 (0.16%)
         occurrences causally related to treatment / all
    2 / 10
    3 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dural arteriovenous fistula
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    6 / 8803 (0.07%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis autoimmune
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Encephalopathy
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    4 / 8803 (0.05%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial nerve disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frontotemporal dementia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    7 / 8803 (0.08%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Headache
         subjects affected / exposed
    7 / 8803 (0.08%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparaesthesia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hemiplegic migraine
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hydrocephalus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    3 / 8803 (0.03%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokinesia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve paresis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Intercostal neuralgia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intensive care unit acquired weakness
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 8803 (0.01%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial hypotension
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial mass
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    79 / 8803 (0.90%)
    80 / 8801 (0.91%)
         occurrences causally related to treatment / all
    3 / 87
    3 / 84
         deaths causally related to treatment / all
    1 / 9
    1 / 8
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    6 / 8803 (0.07%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    5 / 8803 (0.06%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    5 / 8803 (0.06%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningoradiculitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    5 / 8803 (0.06%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Migraine
         subjects affected / exposed
    6 / 8803 (0.07%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine with aura
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelomalacia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgic amyotrophy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occipital neuralgia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonian rest tremor
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve lesion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke seizure
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic headache
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke epilepsy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    14 / 8803 (0.16%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary progressive multiple sclerosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudostroke
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudoradicular syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Relapsing-remitting multiple sclerosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reversible cerebral vasoconstriction syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sciatica
         subjects affected / exposed
    7 / 8803 (0.08%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    14 / 8803 (0.16%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    1 / 14
    2 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Seizure like phenomena
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory loss
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord infarction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal epidural haematoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    6 / 8803 (0.07%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Status migrainosus
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    65 / 8803 (0.74%)
    55 / 8801 (0.62%)
         occurrences causally related to treatment / all
    11 / 71
    3 / 63
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tension headache
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient aphasia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    39 / 8803 (0.44%)
    59 / 8801 (0.67%)
         occurrences causally related to treatment / all
    0 / 42
    0 / 63
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typical aura without headache
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vagus nerve paralysis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo CNS origin
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar stroke
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar artery dissection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute disseminated encephalomyelitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol induced persisting dementia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Focal dyscognitive seizures
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hashimoto's encephalopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Monoparesis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Motor neurone disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Moyamoya disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic tremor
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy alcoholic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral paralysis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic stroke
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord paralysis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    36 / 8803 (0.41%)
    30 / 8801 (0.34%)
         occurrences causally related to treatment / all
    1 / 40
    0 / 38
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Antiphospholipid syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    10 / 8803 (0.11%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolysis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    8 / 8803 (0.09%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoid tissue hyperplasia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Methaemoglobinaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    6 / 8803 (0.07%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of chronic disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Normochromic anaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness neurosensory
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    3 / 8803 (0.03%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    18 / 8803 (0.20%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 18
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute vestibular syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular ataxia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness transient
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    12 / 8803 (0.14%)
    18 / 8801 (0.20%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal degeneration
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal erosion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine ophthalmopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiretinal membrane
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular rupture
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Maculopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular hypertension
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vascular occlusion
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery embolism
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    5 / 8803 (0.06%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous detachment
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreoretinal traction syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract cortical
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatochalasis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lenticular opacities
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual field defect
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    5 / 8803 (0.06%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    9 / 8803 (0.10%)
    18 / 8801 (0.20%)
         occurrences causally related to treatment / all
    2 / 10
    5 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal adhesions
         subjects affected / exposed
    7 / 8803 (0.08%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal symptom
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    11 / 8803 (0.12%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    2 / 12
    4 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 8803 (0.01%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal polyp
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal prolapse
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorectal varices haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendix disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breath odour
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    4 / 8803 (0.05%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    14 / 8803 (0.16%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    4 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    9 / 8803 (0.10%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    3 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colitis ulcerative
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    8 / 8803 (0.09%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    3 / 8
    2 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Crohn's disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental alveolar anomaly
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dieulafoy's vascular malformation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    23 / 8803 (0.26%)
    16 / 8801 (0.18%)
         occurrences causally related to treatment / all
    13 / 23
    4 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    2 / 8803 (0.02%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticulum intestinal
         subjects affected / exposed
    7 / 8803 (0.08%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    2 / 8803 (0.02%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Duodenitis
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    5 / 8803 (0.06%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    4 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    5 / 8803 (0.06%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    3 / 8803 (0.03%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiploic appendagitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enlarged uvula
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive duodenitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eructation
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Gastric polyps
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    5 / 8803 (0.06%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric volvulus
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    14 / 8803 (0.16%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    5 / 14
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         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
    22 / 8803 (0.25%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    1 / 22
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Gastrointestinal inflammation
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal oedema
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation haemorrhagic
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal wall thickening
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    12 / 8803 (0.14%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    5 / 13
    5 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haematemesis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematochezia
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    4 / 8803 (0.05%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Impaired gastric emptying
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    39 / 8803 (0.44%)
    24 / 8801 (0.27%)
         occurrences causally related to treatment / all
    1 / 41
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    11 / 8803 (0.12%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    2 / 11
    2 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal haematoma
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    11 / 8803 (0.12%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukoplakia oral
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 8803 (0.03%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malabsorption
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    6 / 8803 (0.07%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery embolism
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Narcotic bowel syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    12 / 8803 (0.14%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    9 / 12
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema mouth
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    4 / 8803 (0.05%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal disorder
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal polyp
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis ulcerative
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    5 / 8803 (0.06%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    3 / 5
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    9 / 8803 (0.10%)
    14 / 8801 (0.16%)
         occurrences causally related to treatment / all
    4 / 12
    5 / 15
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal hypertensive gastropathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reflux gastritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    10 / 8803 (0.11%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    1 / 10
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 8803 (0.00%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Terminal ileitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toothache
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    9 / 8803 (0.10%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    12 / 8803 (0.14%)
    14 / 8801 (0.16%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Varices oesophageal
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    18 / 8803 (0.20%)
    12 / 8801 (0.14%)
         occurrences causally related to treatment / all
    12 / 18
    3 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia obstructive
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired oesophageal web
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic floor dysfunction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative gastritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dermatitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis contact
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ecchymosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema nummular
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Excessive skin
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purpura fulminans
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Purpura
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin oedema
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lichenoid keratosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus rash
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    79 / 8803 (0.90%)
    105 / 8801 (1.19%)
         occurrences causally related to treatment / all
    12 / 87
    6 / 116
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Anticoagulant-related nephropathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    7 / 8803 (0.08%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    7 / 8803 (0.08%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dysuria
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    16 / 8803 (0.18%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    1 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    6 / 8803 (0.07%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incontinence
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney fibrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower urinary tract symptoms
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microalbuminuria
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Micturition urgency
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    25 / 8803 (0.28%)
    24 / 8801 (0.27%)
         occurrences causally related to treatment / all
    3 / 27
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrosclerosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oliguria
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyuria
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    5 / 8803 (0.06%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cortical necrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal impairment
         subjects affected / exposed
    3 / 8803 (0.03%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular dysfunction
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal vein thrombosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcapsular renal haematoma
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    20 / 8803 (0.23%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    2 / 21
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral meatus stenosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urge incontinence
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 8803 (0.00%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    11 / 8803 (0.12%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urate nephropathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus nephritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal pseudoaneurysm
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal mass
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune thyroiditis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cushing's syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    7 / 8803 (0.08%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graves' disease
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperaldosteronism
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    4 / 8803 (0.05%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoparathyroidism secondary
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic goitre
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroiditis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroiditis acute
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    7 / 8803 (0.08%)
    10 / 8801 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    19 / 8803 (0.22%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    1 / 19
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrofibrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    14 / 8803 (0.16%)
    26 / 8801 (0.30%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone deformity
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone fistula
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    5 / 8803 (0.06%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 8803 (0.00%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibromyalgia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    16 / 8803 (0.18%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint ankylosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb discomfort
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    19 / 8803 (0.22%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle necrosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    13 / 8803 (0.15%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia intercostal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck deformity
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    84 / 8803 (0.95%)
    79 / 8801 (0.90%)
         occurrences causally related to treatment / all
    0 / 93
    0 / 86
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    5 / 8803 (0.06%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    2 / 8803 (0.02%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    13 / 8803 (0.15%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacral pain
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    5 / 8803 (0.06%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    7 / 8803 (0.08%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal synovial cyst
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    5 / 8803 (0.06%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Undifferentiated spondyloarthritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral osteophyte
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse idiopathic skeletal hyperostosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal retrolisthesis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acinetobacter bacteraemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alpha haemolytic streptococcal infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    5 / 8803 (0.06%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    6 / 8803 (0.07%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Appendicitis
         subjects affected / exposed
    18 / 8803 (0.20%)
    16 / 8801 (0.18%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bacteraemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial colitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    9 / 8803 (0.10%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burn infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis mycoplasmal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    124 / 8803 (1.41%)
    137 / 8801 (1.56%)
         occurrences causally related to treatment / all
    0 / 126
    0 / 137
         deaths causally related to treatment / all
    0 / 18
    0 / 31
    COVID-19 pneumonia
         subjects affected / exposed
    119 / 8803 (1.35%)
    148 / 8801 (1.68%)
         occurrences causally related to treatment / all
    1 / 119
    0 / 148
         deaths causally related to treatment / all
    0 / 27
    0 / 35
    Campylobacter gastroenteritis
         subjects affected / exposed
    3 / 8803 (0.03%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    29 / 8803 (0.33%)
    41 / 8801 (0.47%)
         occurrences causally related to treatment / all
    1 / 31
    0 / 43
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic sinusitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial sepsis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    4 / 8803 (0.05%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    2 / 8803 (0.02%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    5 / 8803 (0.06%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis bacterial
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related bacteraemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    14 / 8803 (0.16%)
    23 / 8801 (0.26%)
         occurrences causally related to treatment / all
    1 / 17
    4 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endophthalmitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    10 / 8803 (0.11%)
    13 / 8801 (0.15%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal peritonitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    15 / 8803 (0.17%)
    11 / 8801 (0.12%)
         occurrences causally related to treatment / all
    4 / 16
    4 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal bacterial overgrowth
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes ophthalmic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site cellulitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    9 / 8803 (0.10%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal gangrene
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Joint abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella urinary tract infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    4 / 8803 (0.05%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 8803 (0.06%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphangitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mesenteric abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus pneumonia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycetoma mycotic
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    3 / 8803 (0.03%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    4 / 8803 (0.05%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa candida
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perianal streptococcal infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    3 / 8803 (0.03%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Peritonitis bacterial
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    89 / 8803 (1.01%)
    132 / 8801 (1.50%)
         occurrences causally related to treatment / all
    0 / 102
    2 / 146
         deaths causally related to treatment / all
    0 / 9
    1 / 11
    Pneumonia bacterial
         subjects affected / exposed
    5 / 8803 (0.06%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia chlamydial
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia viral
         subjects affected / exposed
    2 / 8803 (0.02%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    4 / 8803 (0.05%)
    9 / 8801 (0.10%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Post procedural cellulitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    2 / 8803 (0.02%)
    6 / 8801 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    8 / 8803 (0.09%)
    8 / 8801 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic valve endocarditis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pseudoaneurysm infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    11 / 8803 (0.12%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 8803 (0.05%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    5 / 8801 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 sepsis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonella sepsis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal cellulitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    36 / 8803 (0.41%)
    35 / 8801 (0.40%)
         occurrences causally related to treatment / all
    0 / 36
    1 / 35
         deaths causally related to treatment / all
    0 / 6
    0 / 10
    Septic shock
         subjects affected / exposed
    11 / 8803 (0.12%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 15
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Serratia bacteraemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    3 / 8803 (0.03%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Streptococcal sepsis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subperiosteal abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract candidiasis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    32 / 8803 (0.36%)
    43 / 8801 (0.49%)
         occurrences causally related to treatment / all
    1 / 40
    0 / 46
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    14 / 8803 (0.16%)
    14 / 8801 (0.16%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular device infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular graft infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    1 / 8803 (0.01%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection pseudomonas
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cellulitis orbital
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer helicobacter
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex meningitis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective spondylitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Norovirus infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Onychomycosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes simplex
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraspinal abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotid abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic encephalopathy
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma site infection
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    19 / 8803 (0.22%)
    14 / 8801 (0.16%)
         occurrences causally related to treatment / all
    3 / 21
    3 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketosis
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 8803 (0.00%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Food intolerance
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    3 / 8801 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 8803 (0.03%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    3 / 8803 (0.03%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    19 / 8803 (0.22%)
    18 / 8801 (0.20%)
         occurrences causally related to treatment / all
    2 / 25
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    5 / 8803 (0.06%)
    7 / 8801 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    2 / 8803 (0.02%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochloraemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    2 / 8803 (0.02%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malnutrition
         subjects affected / exposed
    2 / 8803 (0.02%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 8803 (0.01%)
    2 / 8801 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 8803 (0.00%)
    4 / 8801 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour lysis syndrome
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 8803 (0.03%)
    15 / 8801 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitamin D deficiency
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acidosis hyperchloraemic
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adult failure to thrive
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 8803 (0.00%)
    1 / 8801 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypernatraemia
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 8803 (0.01%)
    0 / 8801 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
    		 Semaglutide Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3944 / 8803 (44.80%)
    2440 / 8801 (27.72%)
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    715 / 8803 (8.12%)
    231 / 8801 (2.62%)
         occurrences all number
    855
    256
    Vomiting
         subjects affected / exposed
    576 / 8803 (6.54%)
    87 / 8801 (0.99%)
         occurrences all number
    752
    106
    Dyspepsia
         subjects affected / exposed
    468 / 8803 (5.32%)
    94 / 8801 (1.07%)
         occurrences all number
    629
    102
    Nausea
         subjects affected / exposed
    1592 / 8803 (18.08%)
    337 / 8801 (3.83%)
         occurrences all number
    2260
    414
    Diarrhoea
         subjects affected / exposed
    933 / 8803 (10.60%)
    353 / 8801 (4.01%)
         occurrences all number
    1417
    429
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1787 / 8803 (20.30%)
    1785 / 8801 (20.28%)
         occurrences all number
    1933
    1935
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    585 / 8803 (6.65%)
    112 / 8801 (1.27%)
         occurrences all number
    655
    123

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Jan 2021
    The protocol was amended to include: 1) wash-out period and consequently follow-up period and period for contraception use after treatment discontinuation, updated to 5 weeks. 2) WRSSM deleted from supportive secondary endpoints and included in exploratory endpoints. 3) Text revised to simplify the requirements for the naming of the specific process document. 4) Text included for collection of COVID- 19 concomitant medication.
    09 Feb 2022
    The protocol was amended to include: 1) Inclusion of HF composite endpoint in the testing hierarchy. 2) Co-participation in COVID-19 trials was not allowed in Algeria and Germany due to local requirements

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

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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32916609
    http://www.ncbi.nlm.nih.gov/pubmed/36502289
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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