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    Clinical Trial Results:
    Semaglutide cardiovascular outcomes trial in patients with type 2 diabetes (SOUL)

    Summary
    EudraCT number
    		 2018-003141-42
    Trial protocol
    		 DK   NL   GB   SK   DE   BE   AT   ES   CZ   FR   HR   IT   RO  
    Global end of trial date
    23 Aug 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Sep 2025
    First version publication date
    09 Sep 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EX9924-4473
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03914326
    WHO universal trial number (UTN)
    		 U1111-1218-5368
    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
    19 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that oral semaglutide lowers the risk of major adverse cardiovascular events (MACE) compared to placebo, both added to standard of care in patients with type 2 diabetes (T2D) and at high risk of cardiovascular (CV) events.
    Protection of trial subjects
    The trial was conducted in accordance with the Declaration of Helsinki (Oct 2013) and ICH Good Clinical Practice, including archiving of essential documents (May 1996) and EN ISO 14155 Part 1 and 2 and FDA 21 CFR 312.120.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jun 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 413
    Country: Number of subjects enrolled
    Austria: 111
    Country: Number of subjects enrolled
    Belgium: 110
    Country: Number of subjects enrolled
    Brazil: 283
    Country: Number of subjects enrolled
    Canada: 314
    Country: Number of subjects enrolled
    China: 60
    Country: Number of subjects enrolled
    Colombia: 111
    Country: Number of subjects enrolled
    Czechia: 181
    Country: Number of subjects enrolled
    Germany: 313
    Country: Number of subjects enrolled
    Denmark: 110
    Country: Number of subjects enrolled
    Spain: 205
    Country: Number of subjects enrolled
    France: 90
    Country: Number of subjects enrolled
    United Kingdom: 375
    Country: Number of subjects enrolled
    Hong Kong: 80
    Country: Number of subjects enrolled
    Croatia: 191
    Country: Number of subjects enrolled
    India: 788
    Country: Number of subjects enrolled
    Israel: 189
    Country: Number of subjects enrolled
    Italy: 199
    Country: Number of subjects enrolled
    Japan: 408
    Country: Number of subjects enrolled
    Korea, Republic of: 148
    Country: Number of subjects enrolled
    Mexico: 417
    Country: Number of subjects enrolled
    Malaysia: 206
    Country: Number of subjects enrolled
    Netherlands: 171
    Country: Number of subjects enrolled
    Romania: 200
    Country: Number of subjects enrolled
    Russian Federation: 535
    Country: Number of subjects enrolled
    Serbia: 314
    Country: Number of subjects enrolled
    Slovakia: 317
    Country: Number of subjects enrolled
    Thailand: 205
    Country: Number of subjects enrolled
    Türkiye: 314
    Country: Number of subjects enrolled
    Taiwan: 80
    Country: Number of subjects enrolled
    Ukraine: 329
    Country: Number of subjects enrolled
    United States: 1598
    Country: Number of subjects enrolled
    South Africa: 285
    Worldwide total number of subjects
    9650
    EEA total number of subjects
    2198
    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)
    4034
    From 65 to 84 years
    5581
    85 years and over
    35

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was conducted at 446 sites in 34 countries.

    Pre-assignment
    Screening details
    		 A total of 9,651 subjects were enrolled/randomized (1:1) to treatment with oral semaglutide (4,825 subjects) or placebo (4,826 subjects). One subject was randomised twice in the trial. Thus, the FAS comprised 9,650 subjects (4,825 subjects in the oral semaglutide group and 4,825 subjects in the placebo group).

    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
    		 Investigator, Subject, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Oral Semaglutide
    Arm description
    		 Subjects were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Semaglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Semaglutide was administered orally once daily.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Semaglutide matched placebo was administered orally once daily.

    Number of subjects in period 1
    		Oral Semaglutide Placebo
    Started
    4825
    4825
    Full analysis set
    4825
    4825
    Exposed
    4814
    4816
    Completed
    4755
    4740
    Not completed
    70
    85
         Consent withdrawn by subject
    27
    34
         Lost to follow-up
    43
    51

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Oral Semaglutide
    Reporting group description
    		 Subjects were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260).

    Reporting group values
    		 Oral Semaglutide Placebo Total
    Number of subjects
    		 4825 4825 9650
    Age Categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 2058 1976 4034
        From 65-84 years
    		 2750 2831 5581
        85 years and over
    		 17 18 35
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.1 ( 7.6 ) 66.1 ( 7.5 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 1376 1414 2790
        Male
    		 3449 3411 6860

    End points

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    End points reporting groups
    Reporting group title
    Oral Semaglutide
    Reporting group description
    		 Subjects were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260).

    Primary: Number of subjects from randomization to first occurrence of a major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death/non-fatal myocardial infarction/non-fatal stroke

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    End point title
    		 Number of subjects from randomization to first occurrence of a major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death/non-fatal myocardial infarction/non-fatal stroke
    End point description
    Number of subjects with first occurrence of EAC (event adjudication committee) confirmed major adverse cardiovascular event (MACE), a composite end-point. i.e., from time of randomization to first occurrence of cardiovascular (CV) death, non-fatal myocardial infarction and non-fatal stroke combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when subject withdrew consent, date of last contact with subject (for subject lost to follow-up), and date of death. FAS included all unique randomized subject who were grouped according to the treatment assigned at randomization.
    End point type
    Primary
    End point timeframe
    From randomisation (week 0) up to week 265
    End point values
    		 Oral Semaglutide Placebo
    Number of subjects analysed
    4825
    4825
    Units: Subjects
    579
    668
    Statistical analysis title
    		 Oral Semaglutide versus Placebo
    Statistical analysis description
    Time from randomisation to first EAC-confirmed MACE was analysed using a Cox proportional hazards model with treatment as categorical fixed factor.
    Comparison groups
    Oral Semaglutide v Placebo
    Number of subjects included in analysis
    9650
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0028
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.96

    Secondary: Number of subjects from randomization to first occurrence of CV death;renal death;onset of persistent≥50% reduction in eGFR(CKD-EPI);onset of persistent eGFR(CKD-EPI)<15 mL/min/1.73m^2;initiation of chronic renal replacement therapy

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    End point title
    		 Number of subjects from randomization to first occurrence of CV death;renal death;onset of persistent≥50% reduction in eGFR(CKD-EPI);onset of persistent eGFR(CKD-EPI)<15 mL/min/1.73m^2;initiation of chronic renal replacement therapy
    End point description
    Number of subjects with first occurrence of a composite endpoint. i.e., from time of randomization to first occurrence of CV death, renal death, onset of persistent greater than or equal to (≥) 50% reduction in estimated glomerular filtration rate (eGFR) (chronic kidney disease epidemiology collaboration CKD-EPI), onset of persistent eGFR (CKD-EPI) less than (<)15 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2), initiation of chronic renal replacement therapy (dialysis or kidney transplantation) combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when subject withdrew consent, date of last contact with subject (for subject lost to follow-up), and date of death. FAS included all unique randomized subject who were grouped according to the treatment assigned at randomization.
    End point type
    Secondary
    End point timeframe
    From randomisation (week 0) up to week 265
    End point values
    		 Oral Semaglutide Placebo
    Number of subjects analysed
    4825
    4825
    Units: Subjects
    403
    435
    No statistical analyses for this end point

    Secondary: Number of subjects from randomization to time of occurrence of CV death

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    End point title
    		 Number of subjects from randomization to time of occurrence of CV death
    End point description
    Number of subjects from time of randomization to time to occurrence of EAC confirmed CV death during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when subject withdrew consent, date of last contact with subject (for subject lost to follow-up), and date of death. FAS included all unique randomized subject who were grouped according to the treatment assigned at randomization.
    End point type
    Secondary
    End point timeframe
    From randomisation (week 0) up to week 265
    End point values
    		 Oral Semaglutide Placebo
    Number of subjects analysed
    4825
    4825
    Units: Subjects
    301
    320
    No statistical analyses for this end point

    Secondary: Number of subjects from randomization to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation

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    End point title
    		 Number of subjects from randomization to first occurrence of major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation
    End point description
    Number of subjects from randomization to first occurrence of EAC confirmed major adverse limb events (MALE), a composite endpoint consisting of: acute limb ischemia hospitalisation/chronic limb ischemia hospitalisation combined data during in-trial period were reported. In-trial observation period was defined as the period from date of randomization to the first of (both inclusive): date of follow-up visit, date when subject withdrew consent, date of last contact with subject (for subject lost to follow-up), and date of death. FAS included all unique randomized subject who were grouped according to the treatment assigned at randomization.
    End point type
    Secondary
    End point timeframe
    From randomisation (week 0) up to week 265
    End point values
    		 Oral Semaglutide Placebo
    Number of subjects analysed
    4825
    4825
    Units: Subjects
    71
    99
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Week 0 up to Week 265
    Adverse event reporting additional description
    The safety evaluation data as reported by the investigator was based on the FAS using the in-trial observation period which is defined as the period from date of randomization to the first of (both inclusive):date of follow-up visit,date when subject withdrew consent,date of last contact with subject, and date of death.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were to receive once daily placebo matching oral semaglutide until end of the treatment visit (up to week 260).

    Reporting group title
    Oral Semaglutide
    Reporting group description
    		 Subjects were to receive once daily semaglutide tablets with a dose escalation every 4 weeks in doses 3 mg (week 0 to week 4), 7 mg (week 4 to week 8) until maintenance dose of 14 mg was reached and maintained till the end of treatment visit (up to week 260).

    Serious adverse events
    		 Placebo Oral Semaglutide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2427 / 4825 (50.30%)
    2312 / 4825 (47.92%)
         number of deaths (all causes)
    579
    526
         number of deaths resulting from adverse events
    20
    24
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute lymphocytic leukaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    2 / 4825 (0.04%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Adenocarcinoma
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Adenocarcinoma gastric
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    11 / 4825 (0.23%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenoid cystic carcinoma of salivary gland
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital warts
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apocrine breast carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    9 / 4825 (0.19%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign biliary neoplasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct adenocarcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    9 / 4825 (0.19%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer in situ
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage III
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac valve fibroelastoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix cancer metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervix carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    5 / 4825 (0.10%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 7
         deaths causally related to treatment / all
    0 / 3
    1 / 3
    Cholesteatoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    9 / 4825 (0.19%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Colon cancer metastatic
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Colon cancer recurrent
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage IV
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal adenoma
         subjects affected / exposed
    3 / 4825 (0.06%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         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 III
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    Endometrial adenocarcinoma
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential thrombocythaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicular lymphoma stage IV
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Gastric neoplasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Gastric adenoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal lymphoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glottis carcinoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HER2 positive breast cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic adenoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic cancer stage IV
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    12 / 4825 (0.25%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    2 / 12
    1 / 14
         deaths causally related to treatment / all
    2 / 8
    0 / 8
    Hodgkin's disease nodular sclerosis stage III
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hormone receptor positive breast cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive papillary breast carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    5 / 4825 (0.10%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Kaposi's sarcoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung adenocarcinoma stage I
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    7 / 4825 (0.15%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Lung adenocarcinoma recurrent
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung cancer metastatic
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Lung neoplasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    6 / 4825 (0.12%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 3
    1 / 3
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung squamous cell carcinoma stage III
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung squamous cell carcinoma stage IV
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma stage I
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma stage II
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Malignant peritoneal neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to abdominal wall
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone marrow
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to liver
         subjects affected / exposed
    9 / 4825 (0.19%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 6
    0 / 0
    Metastases to lung
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to pleura
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Metastatic malignant melanoma
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngeal cancer metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm prostate
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodular melanoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    4 / 4825 (0.08%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian cancer stage IV
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 4825 (0.04%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 6
         deaths causally related to treatment / all
    1 / 2
    0 / 6
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neuroendocrine tumour metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    4 / 4825 (0.08%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    3 / 6
         deaths causally related to treatment / all
    0 / 1
    2 / 3
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    3 / 4825 (0.06%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Plasma cell myeloma recurrent
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmablastic lymphoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Primary myelofibrosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    7 / 4825 (0.15%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer stage I
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage II
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    23 / 4825 (0.48%)
    40 / 4825 (0.83%)
         occurrences causally related to treatment / all
    1 / 23
    2 / 40
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Rectal adenocarcinoma
         subjects affected / exposed
    5 / 4825 (0.10%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal cancer
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Rectal cancer stage II
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer stage IV
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer stage I
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    2 / 4825 (0.04%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland adenoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    6 / 4825 (0.12%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal meningioma benign
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer metastatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymic carcinoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue carcinoma stage I
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 the renal pelvis and ureter
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    4 / 4825 (0.08%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Tumour of ampulla of Vater
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyosarcoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Waldenstrom's macroglobulinaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm
         subjects affected / exposed
    4 / 4825 (0.08%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic occlusion
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial rupture
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    12 / 4825 (0.25%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    1 / 12
    1 / 9
         deaths causally related to treatment / all
    1 / 5
    1 / 4
    Brachiocephalic arteriosclerosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Deep vein thrombosis
         subjects affected / exposed
    11 / 4825 (0.23%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    1 / 11
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic macroangiopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    6 / 4825 (0.12%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Embolism arterial
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    3 / 4825 (0.06%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery dissection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haematoma
         subjects affected / exposed
    4 / 4825 (0.08%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    20 / 4825 (0.41%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    1 / 22
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hypertensive crisis
         subjects affected / exposed
    6 / 4825 (0.12%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    6 / 4825 (0.12%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive end-organ damage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    5 / 4825 (0.10%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    9 / 4825 (0.19%)
    27 / 4825 (0.56%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 27
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hypovolaemic shock
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Iliac artery stenosis
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    4 / 4825 (0.08%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic limb pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    6 / 4825 (0.12%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating aortic ulcer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    64 / 4825 (1.33%)
    60 / 4825 (1.24%)
         occurrences causally related to treatment / all
    1 / 75
    3 / 72
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Peripheral artery aneurysm
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    11 / 4825 (0.23%)
    15 / 4825 (0.31%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    11 / 4825 (0.23%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral circulatory failure
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral ischaemia
         subjects affected / exposed
    17 / 4825 (0.35%)
    21 / 4825 (0.44%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    8 / 4825 (0.17%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scalp haematoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Shock haemorrhagic
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subclavian artery occlusion
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial vein thrombosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicophlebitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular occlusion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular calcification
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Aortic valve replacement
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula operation
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    2 / 4825 (0.04%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central venous catheter removal
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniotomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoprostatectomy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dialysis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Finger amputation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric bypass
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodialysis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator replacement
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal polypectomy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leg amputation
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic surgery
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve repair
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve replacement
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosurgery
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polypectomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal transplant
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Revascularisation procedure
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleeve gastrectomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fusion surgery
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylectomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transcatheter aortic valve implantation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethrotomy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasodilation procedure
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Asthenia
         subjects affected / exposed
    10 / 4825 (0.21%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac death
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chest discomfort
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    21 / 4825 (0.44%)
    20 / 4825 (0.41%)
         occurrences causally related to treatment / all
    1 / 21
    2 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    52 / 4825 (1.08%)
    43 / 4825 (0.89%)
         occurrences causally related to treatment / all
    1 / 52
    0 / 43
         deaths causally related to treatment / all
    1 / 52
    0 / 43
    Fatigue
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    2 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Implant site dehiscence
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 inflammation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site joint pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    11 / 4825 (0.23%)
    14 / 4825 (0.29%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 14
         deaths causally related to treatment / all
    0 / 9
    0 / 13
    Non-cardiac chest pain
         subjects affected / exposed
    24 / 4825 (0.50%)
    39 / 4825 (0.81%)
         occurrences causally related to treatment / all
    3 / 25
    1 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacemaker syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic mass
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 stenosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic cardiac valve regurgitation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    6 / 4825 (0.12%)
    15 / 4825 (0.31%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sudden death
         subjects affected / exposed
    19 / 4825 (0.39%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    1 / 19
    2 / 17
         deaths causally related to treatment / all
    1 / 19
    2 / 17
    Sudden cardiac death
         subjects affected / exposed
    10 / 4825 (0.21%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 9
         deaths causally related to treatment / all
    1 / 10
    1 / 9
    Ulcer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    9 / 4825 (0.19%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drug hypersensitivity
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Loss of personal independence in daily activities
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    16 / 4825 (0.33%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    1 / 16
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus prostatic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia with cellular atypia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermenstrual bleeding
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile vascular disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peyronie's disease
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    3 / 4825 (0.06%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    18 / 4825 (0.37%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 17
         deaths causally related to treatment / all
    0 / 6
    0 / 4
    Acute respiratory distress syndrome
         subjects affected / exposed
    5 / 4825 (0.10%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 4
    1 / 2
    Acute respiratory failure
         subjects affected / exposed
    50 / 4825 (1.04%)
    33 / 4825 (0.68%)
         occurrences causally related to treatment / all
    0 / 61
    0 / 43
         deaths causally related to treatment / all
    0 / 13
    0 / 9
    Asphyxia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    1 / 4825 (0.02%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    24 / 4825 (0.50%)
    19 / 4825 (0.39%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 25
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Chronic respiratory failure
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cough
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    24 / 4825 (0.50%)
    19 / 4825 (0.39%)
         occurrences causally related to treatment / all
    1 / 26
    1 / 19
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Dyspnoea exertional
         subjects affected / exposed
    6 / 4825 (0.12%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    6 / 4825 (0.12%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoxia
         subjects affected / exposed
    5 / 4825 (0.10%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung opacity
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural thickening
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    15 / 4825 (0.31%)
    16 / 4825 (0.33%)
         occurrences causally related to treatment / all
    2 / 16
    0 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Pneumonitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pneumothorax
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis aspiration
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    19 / 4825 (0.39%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    1 / 20
    1 / 17
         deaths causally related to treatment / all
    0 / 6
    0 / 6
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary hypertension
         subjects affected / exposed
    5 / 4825 (0.10%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pulmonary mass
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    18 / 4825 (0.37%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory depression
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    27 / 4825 (0.56%)
    24 / 4825 (0.50%)
         occurrences causally related to treatment / all
    0 / 28
    1 / 24
         deaths causally related to treatment / all
    0 / 9
    0 / 12
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord cyst
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord leukoplakia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol use disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Confusional state
         subjects affected / exposed
    7 / 4825 (0.15%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Delirium
         subjects affected / exposed
    7 / 4825 (0.15%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Delusion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusional disorder, unspecified type
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised anxiety disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 4825 (0.02%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tobacco abuse
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device loosening
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device power source issue
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lead dislodgement
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic cardiac valve malfunction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent malfunction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute cholecystitis necrotic
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatic failure
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Alcoholic liver disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    6 / 4825 (0.12%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    1 / 6
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac cirrhosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    9 / 4825 (0.19%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    3 / 9
    4 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    6 / 4825 (0.12%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    4 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    19 / 4825 (0.39%)
    31 / 4825 (0.64%)
         occurrences causally related to treatment / all
    7 / 19
    10 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholestasis
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cholangitis acute
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis chronic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    12 / 4825 (0.25%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    5 / 12
    6 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    30 / 4825 (0.62%)
    29 / 4825 (0.60%)
         occurrences causally related to treatment / all
    10 / 30
    12 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder rupture
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder oedema
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    6 / 4825 (0.12%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hepatic failure
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hepatic function abnormal
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic infarction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic lesion
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatomegaly
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Jaundice cholestatic
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic fatty liver
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Porcelain gallbladder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiocardiogram
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose abnormal
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood sodium decreased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise electrocardiogram abnormal
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident at home
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    11 / 4825 (0.23%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic restenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula occlusion
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Buttock injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation complication
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cement embolism
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         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
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    5 / 4825 (0.10%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Corneal abrasion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    11 / 4825 (0.23%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    1 / 13
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary bypass stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft occlusion
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft stenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.12%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Craniofacial fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cystitis radiation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decompression sickness
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eschar
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extra-axial haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    44 / 4825 (0.91%)
    25 / 4825 (0.52%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 26
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Extraskeletal ossification
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    23 / 4825 (0.48%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    16 / 4825 (0.33%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    1 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flail chest
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis radiation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal stoma necrosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    6 / 4825 (0.12%)
    14 / 4825 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    14 / 4825 (0.29%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    16 / 4825 (0.33%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    2 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immunisation reaction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intentional overdose
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    6 / 4825 (0.12%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Limb traumatic amputation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprocedural myocardial infarction
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Poisoning
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural stroke
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural hypotension
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural inflammation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative delirium
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural shock
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thrombosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural dizziness
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural nausea
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural vomiting
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation pneumonitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    7 / 4825 (0.15%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    14 / 4825 (0.29%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    2 / 14
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    10 / 4825 (0.21%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Scapula fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder fracture
         subjects affected / exposed
    5 / 4825 (0.10%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt stenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skeletal injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    2 / 4825 (0.04%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial rupture
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    9 / 4825 (0.19%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Thermal burn
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Third degree chemical burn of skin
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    5 / 4825 (0.10%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic liver injury
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion-related acute lung injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic arthritis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic arthrosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ulna fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stricture postoperative
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access malfunction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular bypass dysfunction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft restenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    4 / 4825 (0.08%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchogenic cyst
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Developmental hip dysplasia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial bridging
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    22 / 4825 (0.46%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 11
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    Acute left ventricular failure
         subjects affected / exposed
    12 / 4825 (0.25%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    3 / 14
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    229 / 4825 (4.75%)
    175 / 4825 (3.63%)
         occurrences causally related to treatment / all
    13 / 251
    16 / 196
         deaths causally related to treatment / all
    1 / 31
    4 / 31
    Angina pectoris
         subjects affected / exposed
    103 / 4825 (2.13%)
    83 / 4825 (1.72%)
         occurrences causally related to treatment / all
    6 / 111
    2 / 96
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Angina unstable
         subjects affected / exposed
    104 / 4825 (2.16%)
    80 / 4825 (1.66%)
         occurrences causally related to treatment / all
    7 / 117
    1 / 97
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anginal equivalent
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease mixed
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    22 / 4825 (0.46%)
    24 / 4825 (0.50%)
         occurrences causally related to treatment / all
    1 / 22
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    7 / 4825 (0.15%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 6
    Arteriosclerosis coronary artery
         subjects affected / exposed
    12 / 4825 (0.25%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial tachycardia
         subjects affected / exposed
    1 / 4825 (0.02%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial enlargement
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    95 / 4825 (1.97%)
    99 / 4825 (2.05%)
         occurrences causally related to treatment / all
    4 / 111
    3 / 106
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Atrial flutter
         subjects affected / exposed
    11 / 4825 (0.23%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 13
    3 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         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
    10 / 4825 (0.21%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    6 / 4825 (0.12%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bifascicular block
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    9 / 4825 (0.19%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block right
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac ventricular thrombosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    14 / 4825 (0.29%)
    20 / 4825 (0.41%)
         occurrences causally related to treatment / all
    0 / 14
    2 / 22
         deaths causally related to treatment / all
    0 / 12
    0 / 19
    Cardiac amyloidosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    31 / 4825 (0.64%)
    36 / 4825 (0.75%)
         occurrences causally related to treatment / all
    1 / 33
    2 / 36
         deaths causally related to treatment / all
    1 / 29
    1 / 30
    Cardiac asthma
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac discomfort
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    116 / 4825 (2.40%)
    107 / 4825 (2.22%)
         occurrences causally related to treatment / all
    0 / 157
    2 / 141
         deaths causally related to treatment / all
    0 / 23
    0 / 24
    Cardiac failure acute
         subjects affected / exposed
    43 / 4825 (0.89%)
    33 / 4825 (0.68%)
         occurrences causally related to treatment / all
    2 / 51
    1 / 42
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Cardiac failure chronic
         subjects affected / exposed
    33 / 4825 (0.68%)
    33 / 4825 (0.68%)
         occurrences causally related to treatment / all
    5 / 38
    0 / 36
         deaths causally related to treatment / all
    2 / 5
    0 / 10
    Cardiac failure congestive
         subjects affected / exposed
    58 / 4825 (1.20%)
    67 / 4825 (1.39%)
         occurrences causally related to treatment / all
    6 / 65
    6 / 78
         deaths causally related to treatment / all
    1 / 9
    1 / 9
    Cardiac flutter
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    17 / 4825 (0.35%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    1 / 17
    0 / 9
         deaths causally related to treatment / all
    1 / 13
    0 / 5
    Cardiomyopathy
         subjects affected / exposed
    4 / 4825 (0.08%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiovascular disorder
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic coronary syndrome
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    108 / 4825 (2.24%)
    102 / 4825 (2.11%)
         occurrences causally related to treatment / all
    5 / 117
    4 / 105
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Coronary artery insufficiency
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    11 / 4825 (0.23%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery perforation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    47 / 4825 (0.97%)
    43 / 4825 (0.89%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 44
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Defect conduction intraventricular
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dilated cardiomyopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Diastolic dysfunction
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart failure with midrange ejection fraction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart failure with preserved ejection fraction
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Heart failure with reduced ejection fraction
         subjects affected / exposed
    7 / 4825 (0.15%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    7 / 4825 (0.15%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    6 / 4825 (0.12%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Left ventricular dysfunction
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 4825 (0.10%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Myocardial infarction
         subjects affected / exposed
    47 / 4825 (0.97%)
    40 / 4825 (0.83%)
         occurrences causally related to treatment / all
    3 / 48
    3 / 40
         deaths causally related to treatment / all
    2 / 23
    1 / 16
    Myocardial ischaemia
         subjects affected / exposed
    46 / 4825 (0.95%)
    25 / 4825 (0.52%)
         occurrences causally related to treatment / all
    3 / 52
    1 / 26
         deaths causally related to treatment / all
    1 / 8
    0 / 4
    Myocardial rupture
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myopericarditis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    5 / 4825 (0.10%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Right ventricular failure
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    8 / 4825 (0.17%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    5 / 4825 (0.10%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular bradycardia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    4 / 4825 (0.08%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 4825 (0.02%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    Ventricular extrasystoles
         subjects affected / exposed
    5 / 4825 (0.10%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular septal defect acquired
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    20 / 4825 (0.41%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    3 / 21
    0 / 16
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    9 / 4825 (0.19%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia stroke
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar artery aneurysm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basilar artery occlusion
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 4825 (0.00%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Brain oedema
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain stem infarction
         subjects affected / exposed
    6 / 4825 (0.12%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain stem stroke
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brainstem compression
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    7 / 4825 (0.15%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    19 / 4825 (0.39%)
    31 / 4825 (0.64%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    30 / 4825 (0.62%)
    27 / 4825 (0.56%)
         occurrences causally related to treatment / all
    2 / 31
    3 / 28
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Central nervous system lesion
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar atrophy
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar ischaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebellar syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral amyloid angiopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery occlusion
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery stenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral atrophy
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    8 / 4825 (0.17%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    5 / 4825 (0.10%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral small vessel ischaemic disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    38 / 4825 (0.79%)
    30 / 4825 (0.62%)
         occurrences causally related to treatment / all
    2 / 40
    2 / 30
         deaths causally related to treatment / all
    0 / 8
    2 / 10
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral microhaemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cytotoxic lesions of corpus callosum
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    8 / 4825 (0.17%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Demyelinating polyneuropathy
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic hyperosmolar coma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    3 / 4825 (0.06%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Diabetic hyperglycaemic coma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Disturbance in attention
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    6 / 4825 (0.12%)
    14 / 4825 (0.29%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebellar infarction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    6 / 4825 (0.12%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalomalacia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    8 / 4825 (0.17%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epilepsy
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial nerve disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    6 / 4825 (0.12%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 6
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Headache
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiataxia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemihyperaesthesia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    0 / 4825 (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
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersomnia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypnic headache
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    IIIrd nerve paralysis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IVth nerve disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic neuropathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    59 / 4825 (1.22%)
    65 / 4825 (1.35%)
         occurrences causally related to treatment / all
    2 / 67
    2 / 72
         deaths causally related to treatment / all
    0 / 7
    0 / 13
    Lacunar infarction
         subjects affected / exposed
    7 / 4825 (0.15%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    10 / 4825 (0.21%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Migraine
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mixed dementia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Motor neurone disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Middle cerebral artery stroke
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Narcolepsy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occipital neuralgia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    4 / 4825 (0.08%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parietal lobe stroke
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Partial seizures
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve lesion
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial nerve palsy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacral radiculopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    8 / 4825 (0.17%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Senile dementia
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Sensory disturbance
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    4 / 4825 (0.08%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinocerebellar disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    7 / 4825 (0.15%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Syncope
         subjects affected / exposed
    35 / 4825 (0.73%)
    37 / 4825 (0.77%)
         occurrences causally related to treatment / all
    1 / 36
    4 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic stroke
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Toxic encephalopathy
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient aphasia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    43 / 4825 (0.89%)
    42 / 4825 (0.87%)
         occurrences causally related to treatment / all
    2 / 48
    4 / 51
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumefactive multiple sclerosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unresponsive to stimuli
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uraemic encephalopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paresis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular encephalopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery occlusion
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar stroke
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord paresis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia folate deficiency
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    44 / 4825 (0.91%)
    33 / 4825 (0.68%)
         occurrences causally related to treatment / all
    2 / 48
    1 / 39
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Autoimmune haemolytic anaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood loss anaemia
         subjects affected / exposed
    5 / 4825 (0.10%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    14 / 4825 (0.29%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leukopenia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelosuppression
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nephrogenic anaemia
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic anaemia
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Splenic artery perforation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness neurosensory
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis of external ear canal
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Middle ear inflammation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otolithiasis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    9 / 4825 (0.19%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    49 / 4825 (1.02%)
    39 / 4825 (0.81%)
         occurrences causally related to treatment / all
    1 / 59
    0 / 46
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract diabetic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroidal neovascularisation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoid macular oedema
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic eye disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    15 / 4825 (0.31%)
    29 / 4825 (0.60%)
         occurrences causally related to treatment / all
    8 / 16
    15 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinal oedema
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiretinal membrane
         subjects affected / exposed
    5 / 4825 (0.10%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    2 / 5
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    4 / 4825 (0.08%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iritis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meibomian gland dysfunction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular myasthenia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic atrophy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior capsule opacification
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    2 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy proliferative
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tolosa-Hunt syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tractional retinal detachment
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    9 / 4825 (0.19%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    2 / 10
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    6 / 4825 (0.12%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 4825 (0.08%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    3 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute abdomen
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal mucocoele
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    4 / 4825 (0.08%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    3 / 4825 (0.06%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastrointestinal bleeding
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 4825 (0.06%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colitis ulcerative
         subjects affected / exposed
    1 / 4825 (0.02%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 4825 (0.04%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 4
    Constipation
         subjects affected / exposed
    7 / 4825 (0.15%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    1 / 7
    4 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    10 / 4825 (0.21%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    2 / 10
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dieulafoy's vascular malformation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequent bowel movements
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    9 / 4825 (0.19%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Gastrointestinal inflammation
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ischaemia
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    5 / 4825 (0.10%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    16 / 4825 (0.33%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    2 / 16
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    2 / 4825 (0.04%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal wall thickening
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 4825 (0.02%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hernial eventration
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 4825 (0.02%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    15 / 4825 (0.31%)
    28 / 4825 (0.58%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal angina
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Intestinal obstruction
         subjects affected / exposed
    5 / 4825 (0.10%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Large intestinal stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    10 / 4825 (0.21%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukoplakia oral
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant ascites
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    5 / 4825 (0.10%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis ulcerative
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    14 / 4825 (0.29%)
    16 / 4825 (0.33%)
         occurrences causally related to treatment / all
    9 / 18
    12 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pancreatitis chronic
         subjects affected / exposed
    5 / 4825 (0.10%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    3 / 6
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneocutaneous fistula
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    5 / 4825 (0.10%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal perforation
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    6 / 4825 (0.12%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spigelian hernia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen tongue
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue oedema
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    7 / 4825 (0.15%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 4825 (0.10%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    7 / 4825 (0.15%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    2 / 7
    7 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous vasculitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    23 / 4825 (0.48%)
    20 / 4825 (0.41%)
         occurrences causally related to treatment / all
    0 / 25
    1 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dermatitis bullous
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic wound
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema multiforme
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkeratosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic skin ulcer
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanocytic hyperplasia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrobiosis lipoidica diabeticorum
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    17 / 4825 (0.35%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subcutaneous emphysema
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    151 / 4825 (3.13%)
    123 / 4825 (2.55%)
         occurrences causally related to treatment / all
    14 / 177
    17 / 145
         deaths causally related to treatment / all
    1 / 24
    2 / 10
    Anuria
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atonic urinary bladder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder diverticulum
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder metaplasia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder ulcer
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder obstruction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    44 / 4825 (0.91%)
    31 / 4825 (0.64%)
         occurrences causally related to treatment / all
    1 / 46
    1 / 31
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    Cystitis haemorrhagic
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis noninfective
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    3 / 4825 (0.06%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    21 / 4825 (0.44%)
    14 / 4825 (0.29%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 17
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Glomerulosclerosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    8 / 4825 (0.17%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    7 / 4825 (0.15%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive nephropathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney congestion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    13 / 4825 (0.27%)
    20 / 4825 (0.41%)
         occurrences causally related to treatment / all
    0 / 14
    2 / 21
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Nephropathy toxic
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         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 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal atrophy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    9 / 4825 (0.19%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Renal impairment
         subjects affected / exposed
    7 / 4825 (0.15%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal infarct
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stag horn calculus
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    9 / 4825 (0.19%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral meatus stenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    9 / 4825 (0.19%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cushing's syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia of malignancy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hyperparathyroidism primary
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidic goitre
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    7 / 4825 (0.15%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arthrofibrosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    13 / 4825 (0.27%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest wall mass
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chondrocalcinosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dactylitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma muscle
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    7 / 4825 (0.15%)
    18 / 4825 (0.37%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint range of motion decreased
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb deformity
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    14 / 4825 (0.29%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medial tibial stress syndrome
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    2 / 4825 (0.04%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    5 / 4825 (0.10%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    4 / 4825 (0.08%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic arthropathy
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    58 / 4825 (1.20%)
    39 / 4825 (0.81%)
         occurrences causally related to treatment / all
    0 / 66
    0 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    4 / 4825 (0.08%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    6 / 4825 (0.12%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periostitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (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 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    9 / 4825 (0.19%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff tear arthropathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal ligament ossification
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue swelling
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal instability
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    5 / 4825 (0.10%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    6 / 4825 (0.12%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral lateral recess stenosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral osteophyte
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    5 / 4825 (0.10%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abscess of external ear
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Alpha haemolytic streptococcal infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Antibiotic associated colitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 4825 (0.06%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    2 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspergilloma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    3 / 4825 (0.06%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bacteraemia
         subjects affected / exposed
    4 / 4825 (0.08%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bacterial infection
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacteriuria
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biloma infected
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister infected
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone tuberculosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cellulitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchitis
         subjects affected / exposed
    10 / 4825 (0.21%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchopulmonary aspergillosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    141 / 4825 (2.92%)
    121 / 4825 (2.51%)
         occurrences causally related to treatment / all
    0 / 143
    0 / 122
         deaths causally related to treatment / all
    0 / 26
    0 / 19
    COVID-19 pneumonia
         subjects affected / exposed
    182 / 4825 (3.77%)
    138 / 4825 (2.86%)
         occurrences causally related to treatment / all
    1 / 186
    0 / 141
         deaths causally related to treatment / all
    0 / 57
    0 / 33
    Campylobacter colitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    62 / 4825 (1.28%)
    29 / 4825 (0.60%)
         occurrences causally related to treatment / all
    3 / 71
    0 / 32
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Catheter site infection
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis streptococcal
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic hepatitis C
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial sepsis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon gangrene
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Creutzfeldt-Jakob disease
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    6 / 4825 (0.12%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis bacterial
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis escherichia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis klebsiella
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    6 / 4825 (0.12%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Device related infection
         subjects affected / exposed
    5 / 4825 (0.10%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic foot infection
         subjects affected / exposed
    8 / 4825 (0.17%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    3 / 11
    1 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    6 / 4825 (0.12%)
    13 / 4825 (0.27%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal perforated
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Douglas' abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 4825 (0.00%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter bacteraemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal sepsis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epiglottitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis bacterial
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epididymitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottic abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epstein-Barr virus infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    6 / 4825 (0.12%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Escherichia urinary tract infection
         subjects affected / exposed
    7 / 4825 (0.15%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Erysipelas
         subjects affected / exposed
    8 / 4825 (0.17%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Extradural abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal peritonitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    1 / 4825 (0.02%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gas gangrene
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    22 / 4825 (0.46%)
    15 / 4825 (0.31%)
         occurrences causally related to treatment / all
    1 / 24
    0 / 17
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Gastritis bacterial
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    16 / 4825 (0.33%)
    20 / 4825 (0.41%)
         occurrences causally related to treatment / all
    6 / 17
    2 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital infection fungal
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes sepsis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected seroma
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective spondylitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    7 / 4825 (0.15%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intervertebral discitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella urinary tract infection
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Localised infection
         subjects affected / exposed
    5 / 4825 (0.10%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    5 / 4825 (0.10%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis leptospiral
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus pneumonia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morganella infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium chelonae infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    22 / 4825 (0.46%)
    12 / 4825 (0.25%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Orchitis
         subjects affected / exposed
    4 / 4825 (0.08%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    4 / 4825 (0.08%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paracancerous pneumonia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 4825 (0.02%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotid abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perihepatic abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    7 / 4825 (0.15%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peritonsillar abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal disease
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmodium falciparum infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    6 / 4825 (0.12%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pneumonia
         subjects affected / exposed
    129 / 4825 (2.67%)
    129 / 4825 (2.67%)
         occurrences causally related to treatment / all
    1 / 148
    3 / 146
         deaths causally related to treatment / all
    0 / 30
    0 / 19
    Pneumonia acinetobacter
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    15 / 4825 (0.31%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Pneumonia bacterial
         subjects affected / exposed
    12 / 4825 (0.25%)
    19 / 4825 (0.39%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 23
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pneumonia chlamydial
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia influenzal
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         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
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural pneumonia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-acute COVID-19 syndrome
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    7 / 4825 (0.15%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic abscess
         subjects affected / exposed
    4 / 4825 (0.08%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic valve endocarditis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyoderma
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyonephrosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Purulent discharge
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    10 / 4825 (0.21%)
    7 / 4825 (0.15%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    6 / 4825 (0.12%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyomyositis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         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 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    5 / 4825 (0.10%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 sepsis
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Sialoadenitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal cellulitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrub typhus
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    43 / 4825 (0.89%)
    50 / 4825 (1.04%)
         occurrences causally related to treatment / all
    0 / 46
    2 / 57
         deaths causally related to treatment / all
    0 / 11
    0 / 20
    Septic arthritis streptococcal
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    32 / 4825 (0.66%)
    22 / 4825 (0.46%)
         occurrences causally related to treatment / all
    0 / 32
    1 / 22
         deaths causally related to treatment / all
    0 / 18
    0 / 16
    Serratia infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    2 / 4825 (0.04%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    3 / 4825 (0.06%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Splenic abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    2 / 4825 (0.04%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Streptococcal urinary tract infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    4 / 4825 (0.08%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    3 / 4825 (0.06%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Superinfection bacterial
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected COVID-19
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Superinfection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    3 / 4825 (0.06%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Trichomoniasis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    62 / 4825 (1.28%)
    63 / 4825 (1.31%)
         occurrences causally related to treatment / all
    2 / 70
    3 / 69
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         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 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    23 / 4825 (0.48%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 18
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Vascular device infection
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound cellulitis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    5 / 4825 (0.10%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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
    Acetonaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acidosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acidosis hyperchloraemic
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (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 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic ketoacidosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Decreased appetite
         subjects affected / exposed
    2 / 4825 (0.04%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dehydration
         subjects affected / exposed
    13 / 4825 (0.27%)
    17 / 4825 (0.35%)
         occurrences causally related to treatment / all
    0 / 13
    5 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    16 / 4825 (0.33%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    10 / 4825 (0.21%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic ketoacidosis
         subjects affected / exposed
    13 / 4825 (0.27%)
    8 / 4825 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 8
         deaths causally related to treatment / all
    0 / 3
    1 / 2
    Diabetic metabolic decompensation
         subjects affected / exposed
    5 / 4825 (0.10%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Electrolyte imbalance
         subjects affected / exposed
    4 / 4825 (0.08%)
    4 / 4825 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Euglycaemic diabetic ketoacidosis
         subjects affected / exposed
    3 / 4825 (0.06%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glucose tolerance impaired
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 4825 (0.04%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperinsulinaemic hypoglycaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    41 / 4825 (0.85%)
    38 / 4825 (0.79%)
         occurrences causally related to treatment / all
    2 / 49
    2 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic crisis
         subjects affected / exposed
    2 / 4825 (0.04%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    32 / 4825 (0.66%)
    11 / 4825 (0.23%)
         occurrences causally related to treatment / all
    2 / 37
    0 / 12
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Hyperlipasaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypomagnesaemia
         subjects affected / exposed
    5 / 4825 (0.10%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    12 / 4825 (0.25%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoosmolar state
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    8 / 4825 (0.17%)
    10 / 4825 (0.21%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 4825 (0.02%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    44 / 4825 (0.91%)
    37 / 4825 (0.77%)
         occurrences causally related to treatment / all
    17 / 51
    11 / 45
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    12 / 4825 (0.25%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    4 / 4825 (0.08%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    3 / 4825 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lactic acidosis
         subjects affected / exposed
    3 / 4825 (0.06%)
    6 / 4825 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Magnesium metabolism disorder
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 4825 (0.02%)
    2 / 4825 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolic disorder
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    11 / 4825 (0.23%)
    9 / 4825 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Obesity
         subjects affected / exposed
    1 / 4825 (0.02%)
    0 / 4825 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudohyponatraemia
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Starvation ketoacidosis
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 4825 (0.06%)
    5 / 4825 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 4825 (0.00%)
    1 / 4825 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Oral Semaglutide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1599 / 4825 (33.14%)
    1761 / 4825 (36.50%)
    Eye disorders
    Diabetic retinopathy
         subjects affected / exposed
    932 / 4825 (19.32%)
    943 / 4825 (19.54%)
         occurrences all number
    1116
    1122
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    62 / 4825 (1.28%)
    344 / 4825 (7.13%)
         occurrences all number
    66
    442
    Infections and infestations
    COVID-19
         subjects affected / exposed
    777 / 4825 (16.10%)
    756 / 4825 (15.67%)
         occurrences all number
    836
    838

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Dec 2020
    Protocol Amendment 2.0: The exclusion and discontinuation criteria were amended to allow for simultaneous participation in COVID-19 trials. In addition, the AE collection was expanded to include the reporting of non-serious COVID-19 events

    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
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