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    Clinical Trial Results:
    A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular OutcoMes for People using Anticoagulation StrategieS)

    Summary
    EudraCT number
    		 2012-004180-43
    Trial protocol
    		 IE   SE   CZ   FI   IT   HU   NL   GB   SK   DK   BE  
    Global end of trial date
    15 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2022
    First version publication date
    01 Jun 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    15786
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01776424
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, ​+49 30 300139003, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Jun 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary objectives for rivaroxaban randomization were to determine whether rivaroxaban 2.5 mg twice daily (bid)/ aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction (MI), stroke, or cardiovascular (CV) death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); and to determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of MI, stroke or CV death in subjects with CAD or PAD.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 Subjects not on continuous proton pump inhibitor (PPI) at randomization were additionally randomized to pantoprazole 40 mg, once daily or pantoprazole placebo.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Feb 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 14 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 2443
    Country: Number of subjects enrolled
    United States: 1475
    Country: Number of subjects enrolled
    Australia: 353
    Country: Number of subjects enrolled
    Belgium: 455
    Country: Number of subjects enrolled
    Switzerland: 58
    Country: Number of subjects enrolled
    Germany: 766
    Country: Number of subjects enrolled
    Denmark: 575
    Country: Number of subjects enrolled
    Finland: 119
    Country: Number of subjects enrolled
    France: 191
    Country: Number of subjects enrolled
    United Kingdom: 541
    Country: Number of subjects enrolled
    Ireland: 382
    Country: Number of subjects enrolled
    Israel: 263
    Country: Number of subjects enrolled
    Italy: 1014
    Country: Number of subjects enrolled
    Netherlands: 2522
    Country: Number of subjects enrolled
    Sweden: 735
    Country: Number of subjects enrolled
    South Africa: 581
    Country: Number of subjects enrolled
    Czechia: 1553
    Country: Number of subjects enrolled
    Hungary: 734
    Country: Number of subjects enrolled
    Poland: 518
    Country: Number of subjects enrolled
    Romania: 423
    Country: Number of subjects enrolled
    Russian Federation: 682
    Country: Number of subjects enrolled
    Slovakia: 92
    Country: Number of subjects enrolled
    Ukraine: 821
    Country: Number of subjects enrolled
    China: 1086
    Country: Number of subjects enrolled
    Japan: 1556
    Country: Number of subjects enrolled
    Korea, Republic of: 415
    Country: Number of subjects enrolled
    Malaysia: 247
    Country: Number of subjects enrolled
    Philippines: 651
    Country: Number of subjects enrolled
    Argentina: 2789
    Country: Number of subjects enrolled
    Brazil: 1515
    Country: Number of subjects enrolled
    Chile: 641
    Country: Number of subjects enrolled
    Colombia: 942
    Country: Number of subjects enrolled
    Ecuador: 257
    Worldwide total number of subjects
    27395
    EEA total number of subjects
    10079
    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)
    6517
    From 65 to 84 years
    20870
    85 years and over
    8

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Study was conducted at 608 centers with randomized subjects in 33 countries between 28 Feb 2013 (first patient first visit) and 15 Jun 2021 (last patient last visit of long-term open-label extension part).

    Pre-assignment
    Screening details
    		 Overall, 29872 subjects were screened, of which 2477 subjects were screen failures. A total of 27395 subjects were randomized to antithrombotic treatment. 17598 subjects were randomized to pantoprazole/placebo treatment. 12964 subjects joined long-term open-label extension (LTOLE) part.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rivaroxaban 2.5mg + Aspirin 100mg
    Arm description
    		 Subjects received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    BAY59-7939
    Other name
    Xarelto
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 2.5 mg, twice daily, oral

    Investigational medicinal product name
    Pantoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 40 mg, once daily, oral, for subjects who were not on a PPI and who were randomized to pantoprazole

    Investigational medicinal product name
    Pantoprazole placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pantoprazole matching placebo, once daily, oral, for subjects who were not on a PPI and who were randomized to pantoprazole placebo

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 100 mg, once daily, oral

    Arm title
    		 Rivaroxaban 5mg + Aspirin Placebo
    Arm description
    		 Subjects received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    BAY59-7939
    Other name
    Xarelto
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 5 mg, twice daily, oral

    Investigational medicinal product name
    Aspirin Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Aspirin matching placebo, once daily, oral

    Investigational medicinal product name
    Pantoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 40 mg, once daily, oral, for subjects who were not on a PPI and who were randomized to pantoprazole

    Investigational medicinal product name
    Pantoprazole placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pantoprazole matching placebo, once daily, oral, for subjects who were not on a PPI and who were randomized to pantoprazole placebo

    Arm title
    		 Rivaroxaban Placebo + Aspirin 100mg
    Arm description
    		 Subjects received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rivaroxaban matching placebo, twice daily, oral

    Investigational medicinal product name
    Pantoprazole placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Pantoprazole matching placebo, once daily, oral, for subjects who were not on a PPI and who were randomized to pantoprazole placebo

    Investigational medicinal product name
    Pantoprazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 40 mg, once daily, oral, for subjects who were not on a PPI and who were randomized to pantoprazole

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 100 mg, once daily, oral

    Number of subjects in period 1
    		Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg
    Started
    9152
    9117
    9126
    Treated with antithrombotic treatment
    9134
    9109
    9107
    Randomized to study pantoprazole/placebo
    5878 [1]
    5859 [2]
    5861 [3]
    Completed
    9132
    9098
    9102
    Not completed
    20
    19
    24
         Consent withdrawn by subject
    10
    11
    15
         Lost to follow-up
    10
    8
    9
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects under antithrombotic treatment who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole or matching placebo.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects under antithrombotic treatment who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole or matching placebo.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: Subjects under antithrombotic treatment who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole or matching placebo.
    Period 2
    Period 2 title
    LTOLE part (open label)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 LTOLE part: Rivaroxaban 2.5mg + Aspirin 100mg
    Arm description
    		 Subjects who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 100 mg, once daily, oral

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    BAY59-7939
    Other name
    Xarelto
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet, 2.5 mg, twice daily, oral

    Number of subjects in period 2 [4]
    		LTOLE part: Rivaroxaban 2.5mg + Aspirin 100mg
    Started
    12964
    Treated in LTOLE part
    12903
    Completed
    12745
    Not completed
    219
         Missing final visit
    188
         Lost to follow-up
    13
         Refused
    18
    Notes
    [4] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Subjects from antithrombotic study part who gave their written informed consent to participate in the LTOLE part and who met the eligibility criteria were included in the LTOLE study part.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban 2.5mg + Aspirin 100mg
    Reporting group description
    		 Subjects received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.

    Reporting group title
    Rivaroxaban 5mg + Aspirin Placebo
    Reporting group description
    		 Subjects received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.

    Reporting group title
    Rivaroxaban Placebo + Aspirin 100mg
    Reporting group description
    		 Subjects received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.

    Reporting group values
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg Total
    Number of subjects
    		 9152 9117 9126 27395
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.3 ( 7.9 ) 68.2 ( 7.9 ) 68.2 ( 8.0 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 2059 1972 1989 6020
        Male
    		 7093 7145 7137 21375
    Race/Ethnicity
    Units: Subjects
        Chinese
    		 388 381 376 1145
        Hispanic
    		 1769 1751 1758 5278
        White/Caucasian
    		 5673 5672 5682 17027
        South Asian
    		 107 102 106 315
        Other Asian
    		 956 938 915 2809
        Black/African American
    		 76 94 92 262
        Other
    		 183 179 197 559

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Rivaroxaban 2.5mg + Aspirin 100mg
    Reporting group description
    		 Subjects received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.

    Reporting group title
    Rivaroxaban 5mg + Aspirin Placebo
    Reporting group description
    		 Subjects received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.

    Reporting group title
    Rivaroxaban Placebo + Aspirin 100mg
    Reporting group description
    		 Subjects received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od.
    Reporting group title
    LTOLE part: Rivaroxaban 2.5mg + Aspirin 100mg
    Reporting group description
    		 Subjects who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

    Subject analysis set title
    Intent-to-treatment Analysis Set (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT included all subjects randomized to antithrombotic treatment for the initial study part. The ITT set comprised both subjects randomized to pantoprazole/placebo and subjects not randomized to pantoprazole/placebo.

    Subject analysis set title
    LTOLE Intent-to-treat Analysis Set (LTOLE ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    LTOLE ITT included all subjects who completed COMPASS LTOLE initiation visit (LTOLE initiation visit date entered).

    Subject analysis set title
    LTOLE Safety Analysis Set (LTOLE SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    LTOLE SAF: included all subjects who completed COMPASS LTOLE initiation visit and who received at least one dose of medication in LTOLE part.

    Primary: The first occurrence of the composite primary efficacy outcome, myocardial infarction (MI), stroke, or cardiovascular (CV) death

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    End point title
    		 The first occurrence of the composite primary efficacy outcome, myocardial infarction (MI), stroke, or cardiovascular (CV) death
    End point description
    Count of subjects and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    End point type
    Primary
    End point timeframe
    For each subject, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
    End point values
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects analysed
    9152 [1]
    9117 [2]
    9126 [3]
    Units: Subjects
    379
    448
    496
    Notes
    [1] - ITT
    [2] - ITT
    [3] - ITT
    Statistical analysis title
    		 Time to first composite primary efficacy outcome
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 2.5mg + Aspirin 100mg v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18278
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00004 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.86
    Notes
    [4] - Independent DSMB recommended to stop rivaroxaban/aspirin arms on 06FEB2017. At first interim analysis(~50% events) the log-rank test statistic for one primary comparison had crossed the modified Haybittle-Peto boundary(z=4) consistently over 3 months
    Statistical analysis title
    		 Time to first composite primary efficacy outcome
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 5mg + Aspirin Placebo v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1149
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.03

    Primary: The first occurrence of the primary safety outcome major bleeding based on a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria

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    End point title
    		 The first occurrence of the primary safety outcome major bleeding based on a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria
    End point description
    Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of subjects and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    End point type
    Primary
    End point timeframe
    For each subject, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
    End point values
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects analysed
    9152 [5]
    9117 [6]
    9126 [7]
    Units: Subjects
    288
    255
    170
    Notes
    [5] - ITT
    [6] - ITT
    [7] - ITT
    Statistical analysis title
    		 Time to first primary safety outcome
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 2.5mg + Aspirin 100mg v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18278
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.00001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 2.05
    Statistical analysis title
    		 Time to first primary safety outcome
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and Stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 5mg + Aspirin Placebo v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00003
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.84

    Secondary: The first occurrence of myocardial infarction (MI), ischemic stroke, acute limb ischemia (ALI), or coronary heart disease (CHD) death

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    End point title
    		 The first occurrence of myocardial infarction (MI), ischemic stroke, acute limb ischemia (ALI), or coronary heart disease (CHD) death
    End point description
    Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    End point type
    Secondary
    End point timeframe
    For each subject, the first occurrence of MI, ischemic stroke, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
    End point values
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects analysed
    9152
    9117
    9126
    Units: Subjects
    329
    397
    450
    Statistical analysis title
    		 Time to first MI, ischemic stroke,ALI or CHD death
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 2.5mg + Aspirin 100mg v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18278
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00001 [8]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.83
    Notes
    [8] - Nominal p-value
    Statistical analysis title
    		 Time to first MI, ischemic stroke,ALI or CHD death
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 5mg + Aspirin Placebo v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.06437
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.01
    Notes
    [9] - Nominal p-value

    Secondary: The first occurrence of MI, ischemic stroke, ALI, or cardiovascular (CV) death

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    End point title
    		 The first occurrence of MI, ischemic stroke, ALI, or cardiovascular (CV) death
    End point description
    Count of subjects and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    End point type
    Secondary
    End point timeframe
    For each subject, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
    End point values
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects analysed
    9152 [10]
    9117 [11]
    9126 [12]
    Units: Subjects
    389
    453
    516
    Notes
    [10] - ITT
    [11] - ITT
    [12] - ITT
    Statistical analysis title
    		 Time to first MI, ischemic stroke, ALI or CV death
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 2.5mg + Aspirin 100mg v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18278
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00001 [13]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.85
    Notes
    [13] - Nominal p-value
    Statistical analysis title
    		 Time to first MI, ischemic stroke, ALI or CV death
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 5mg + Aspirin Placebo v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.03995 [14]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.99
    Notes
    [14] - Nominal p-value

    Secondary: All-cause mortality

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    End point title
    		 All-cause mortality
    End point description
    Count of subjects and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
    End point type
    Secondary
    End point timeframe
    For each subjects, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
    End point values
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects analysed
    9152 [15]
    9117 [16]
    9126 [17]
    Units: Subjects
    313
    366
    378
    Notes
    [15] - ITT
    [16] - ITT
    [17] - ITT
    Statistical analysis title
    		 Time to death by all cause
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 2.5mg + Aspirin 100mg v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18278
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01062 [18]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.96
    Notes
    [18] - Nominal p-value
    Statistical analysis title
    		 Time to death by all cause
    Statistical analysis description
    Log-rank test stratified by pantoprazole randomization and stratified Cox proportional hazards model were used in the analyses.
    Comparison groups
    Rivaroxaban 5mg + Aspirin Placebo v Rivaroxaban Placebo + Aspirin 100mg
    Number of subjects included in analysis
    18243
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.66418 [19]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.12
    Notes
    [19] - Nominal p-value

    Other pre-specified: The first occurrence of the primary safety outcome major bleeding based on a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria in LTOLE part

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    End point title
    		 The first occurrence of the primary safety outcome major bleeding based on a modification of the International Society on Thrombosis and Haemostasis (ISTH) criteria in LTOLE part
    End point description
    Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day). Count of subjects from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated.
    End point type
    Other pre-specified
    End point timeframe
    For each subject, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days.
    End point values
    		 LTOLE part: Rivaroxaban 2.5mg + Aspirin 100mg
    Number of subjects analysed
    12903 [20]
    Units: Subjects
    138
    Notes
    [20] - LTOLE SAF
    No statistical analyses for this end point

    Other pre-specified: All-cause mortality in LTOLE part

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    End point title
    		 All-cause mortality in LTOLE part
    End point description
    Count of subjects from COMPASS LTOLE initiation visit to death by all cause were evaluated.
    End point type
    Other pre-specified
    End point timeframe
    For each subjects, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days.
    End point values
    		 LTOLE part: Rivaroxaban 2.5mg + Aspirin 100mg
    Number of subjects analysed
    12964 [21]
    Units: Subjects
    282
    Notes
    [21] - LTOLE ITT
    No statistical analyses for this end point

    Other pre-specified: The first occurrence of the composite primary efficacy outcome, myocardial infarction (MI), stroke, or cardiovascular (CV) death in LTOLE part

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    End point title
    		 The first occurrence of the composite primary efficacy outcome, myocardial infarction (MI), stroke, or cardiovascular (CV) death in LTOLE part
    End point description
    Count of subjects from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated.
    End point type
    Other pre-specified
    End point timeframe
    For each subject, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days.
    End point values
    		 LTOLE part: Rivaroxaban 2.5mg + Aspirin 100mg
    Number of subjects analysed
    12964 [22]
    Units: Subjects
    353
    Notes
    [22] - LTOLE ITT
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization up to 2 days following permanent discontinuation of any antithrombotic study treatment, with an average duration of about 3 years (including a mean duration of 478 days between end of antithrombotic study part and start of LTOLE part)
    Adverse event reporting additional description
    All-Cause Mortality reporting in the AE section encompasses all death cases in the entire safety analysis set (SAF) before the last contact visit, with an average duration of about 3 years. Two subjects who received treatment in LTOLE part but were never treated in antithrombotic study, therefore the entire SAF comprised 27352 subjects.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    Rivaroxaban 2.5mg + Aspirin 100mg
    Reporting group description
    		 Subjects received rivaroxaban 2.5 mg twice daily (bid) and aspirin 100 mg once daily (od). All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a proton pump inhibitor (PPI), were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Subjects who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

    Reporting group title
    Rivaroxaban Placebo + Aspirin 100mg
    Reporting group description
    		 Subjects received rivaroxaban placebo bid and aspirin 100 mg od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Subjects who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

    Reporting group title
    Rivaroxaban 5mg + Aspirin Placebo
    Reporting group description
    		 Subjects received rivaroxaban 5 mg bid and aspirin placebo od. All doses were provided in tablet form for oral administration. Subjects who did not have a continuous need to take a PPI, were additionally randomized 1:1 to receive pantoprazole 40 mg (tablet form for oral administration, od) or matching placebo od. Subjects who consented to LTOLE part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part.

    Serious adverse events
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban Placebo + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    781 / 9135 (8.55%)
    715 / 9108 (7.85%)
    755 / 9109 (8.29%)
         number of deaths (all causes)
    631
    657
    653
         number of deaths resulting from adverse events
    185
    181
    166
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenoma benign
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Biliary neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    3 / 9135 (0.03%)
    8 / 9108 (0.09%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Breast cancer
         subjects affected / exposed
    7 / 9135 (0.08%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Cervix carcinoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    Colon cancer
         subjects affected / exposed
    10 / 9135 (0.11%)
    6 / 9108 (0.07%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    Cholesteatoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibroma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer stage IV
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gallbladder cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gastric cancer
         subjects affected / exposed
    8 / 9135 (0.09%)
    6 / 9108 (0.07%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Haemangioma of skin
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial tumour haemorrhage
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypopharyngeal cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Laryngeal neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 3
    0 / 1
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Lymphoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of spermatic cord
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Meningioma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Mesothelioma malignant
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Metastases to liver
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Metastases to lung
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Metastases to neck
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 9135 (0.00%)
    7 / 9108 (0.08%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 7
    0 / 5
    Oesophageal carcinoma
         subjects affected / exposed
    2 / 9135 (0.02%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    4 / 9135 (0.04%)
    2 / 9108 (0.02%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 5
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile cancer
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Plasma cell myeloma
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Polycythaemia vera
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    3 / 9135 (0.03%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal cancer
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Small intestine carcinoma metastatic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheal cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    2 / 9135 (0.02%)
    5 / 9108 (0.05%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    Colon adenoma
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Metastases to peritoneum
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain cancer metastatic
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    15 / 9135 (0.16%)
    6 / 9108 (0.07%)
    10 / 9109 (0.11%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
    Metastases to central nervous system
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural neoplasm
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    20 / 9135 (0.22%)
    15 / 9108 (0.16%)
    15 / 9109 (0.16%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 16
    1 / 15
         deaths causally related to treatment / all
    0 / 19
    0 / 15
    0 / 12
    Cancer pain
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Malignant mesenchymoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral nervous system neoplasm
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic marginal zone lymphoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillar neoplasm
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal cancer
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Colon cancer stage 0
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ameloblastoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer metastatic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    3 / 9135 (0.03%)
    5 / 9108 (0.05%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    0 / 2
    Hepatocellular carcinoma
         subjects affected / exposed
    4 / 9135 (0.04%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Central nervous system neuroblastoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adrenal gland cancer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour of the lung
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Adenocarcinoma metastatic
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Follicular lymphoma
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    2 / 9135 (0.02%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Orthostatic hypotension
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renovascular hypertension
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dry gangrene
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic rupture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    4 / 9135 (0.04%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Peripheral artery aneurysm rupture
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atheroembolism
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Carotid endarterectomy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriovenous fistula operation
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery surgery
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot amputation
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric polypectomy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia hiatus repair
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia repair
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mole excision
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ptosis repair
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal polypectomy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia repair
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glaucoma surgery
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary angioplasty
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus management
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transurethral bladder resection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sigmoidectomy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint arthroplasty
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia repair
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin neoplasm excision
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shoulder operation
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth extraction
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    2 / 9135 (0.02%)
    6 / 9108 (0.07%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm surgery
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal endoscopic therapy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stoma closure
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheter management
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal polypectomy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    10 / 9135 (0.11%)
    6 / 9108 (0.07%)
    14 / 9109 (0.15%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    5 / 9135 (0.05%)
    7 / 9108 (0.08%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    0 / 6
    Generalised oedema
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Euthanasia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pyrexia
         subjects affected / exposed
    2 / 9135 (0.02%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Unevaluable event
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Accidental death
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    Non-cardiac chest pain
         subjects affected / exposed
    10 / 9135 (0.11%)
    8 / 9108 (0.09%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device site erosion
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 9135 (0.03%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    Lithiasis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Contrast media reaction
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Pregnancy of partner
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatic haemorrhage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    7 / 9135 (0.08%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    Acute respiratory failure
         subjects affected / exposed
    5 / 9135 (0.05%)
    8 / 9108 (0.09%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 9135 (0.01%)
    4 / 9108 (0.04%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    Cough
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    6 / 9135 (0.07%)
    7 / 9108 (0.08%)
    13 / 9109 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    Choking
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Nasal polyps
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    4 / 9135 (0.04%)
    5 / 9108 (0.05%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pleurisy
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary vasculitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory disorder
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Respiratory distress
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    5 / 9135 (0.05%)
    9 / 9108 (0.10%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    0 / 7
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Throat irritation
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory acidosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial polyp
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal mass
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired diaphragmatic eventration
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cough variant asthma
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute interstitial pneumonitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper airway obstruction
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Negative pressure pulmonary oedema
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol abuse
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    Delirium
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Depression
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stereotypy
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    4 / 9135 (0.04%)
    3 / 9108 (0.03%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 9135 (0.03%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    10 / 9135 (0.11%)
    12 / 9108 (0.13%)
    9 / 9109 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    7 / 9135 (0.08%)
    10 / 9108 (0.11%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    5 / 9135 (0.05%)
    6 / 9108 (0.07%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    Cirrhosis alcoholic
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic mass
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary obstruction
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Amylase increased
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood glucose abnormal
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biopsy prostate
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchoscopy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HIV test positive
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipase increased
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urological examination
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angiogram peripheral
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Computerised tomogram thorax
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood electrolytes abnormal
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angiocardiogram
         subjects affected / exposed
    10 / 9135 (0.11%)
    12 / 9108 (0.13%)
    9 / 9109 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 14
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis B core antibody positive
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stenotrophomonas test positive
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blindness traumatic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Chemical poisoning
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Fall
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body in eye
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    3 / 9135 (0.03%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    4 / 9135 (0.04%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Poisoning deliberate
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    5 / 9135 (0.05%)
    3 / 9108 (0.03%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
    Spinal compression fracture
         subjects affected / exposed
    2 / 9135 (0.02%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain contusion
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infusion related reaction
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative renal failure
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pelvic fracture
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder injury
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular bypass dysfunction
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular anastomosis aneurysm
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural swelling
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Airway burns
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fabry's disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    4 / 9135 (0.04%)
    11 / 9108 (0.12%)
    7 / 9109 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Cor pulmonale
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amnesia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bell's palsy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral venous thrombosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Demyelination
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Headache
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Monoplegia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Motor neurone disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Temporal lobe epilepsy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    6 / 9135 (0.07%)
    7 / 9108 (0.08%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 9135 (0.00%)
    3 / 9108 (0.03%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    3 / 9135 (0.03%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uraemic encephalopathy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo CNS origin
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cubital tunnel syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Putamen haemorrhage
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuromuscular pain
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    14 / 9135 (0.15%)
    5 / 9108 (0.05%)
    10 / 9109 (0.11%)
         occurrences causally related to treatment / all
    7 / 15
    3 / 5
    7 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 9135 (0.04%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    5 / 9135 (0.05%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pernicious anaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypereosinophilic syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood disorder
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic diathesis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    2 / 9135 (0.02%)
    6 / 9108 (0.07%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deafness bilateral
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear discomfort
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness transient
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract cortical
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    17 / 9135 (0.19%)
    7 / 9108 (0.08%)
    11 / 9109 (0.12%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ophthalmoplegia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pterygium
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden visual loss
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tolosa-Hunt syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Entropion
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal vascular thrombosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Age-related macular degeneration
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    4 / 9135 (0.04%)
    5 / 9108 (0.05%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    5 / 9135 (0.05%)
    5 / 9108 (0.05%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    Acute abdomen
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Anal fistula
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Barrett's oesophagus
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    5 / 9135 (0.05%)
    3 / 9108 (0.03%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal perforation
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallstone ileus
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    6 / 9135 (0.07%)
    5 / 9108 (0.05%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    3 / 7
    1 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis alcoholic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 9135 (0.05%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    5 / 7
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    6 / 9135 (0.07%)
    5 / 9108 (0.05%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    Large intestine perforation
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Intestinal obstruction
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    4 / 9135 (0.04%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    6 / 9135 (0.07%)
    12 / 9108 (0.13%)
    12 / 9109 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    Pancreatitis haemorrhagic
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    Pancreatitis chronic
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    6 / 9135 (0.07%)
    13 / 9108 (0.14%)
    7 / 9109 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spigelian hernia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyschezia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastric antral vascular ectasia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    8 / 9135 (0.09%)
    9 / 9108 (0.10%)
    15 / 9109 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal rupture
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal toxicity
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric mucosal lesion
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic enteritis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Omental infarction
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subacute pancreatitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 9135 (0.01%)
    5 / 9108 (0.05%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis exfoliative generalised
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ingrowing nail
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity vasculitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema multiforme
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lichen planus
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatomyositis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash pruritic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukoplakia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria chronic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Capillaritis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    6 / 9135 (0.07%)
    4 / 9108 (0.04%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    8 / 9135 (0.09%)
    6 / 9108 (0.07%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    Renal tubular necrosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder mass
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Renal impairment
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    4 / 9135 (0.04%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urogenital disorder
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    4 / 9135 (0.04%)
    4 / 9108 (0.04%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    32 / 9135 (0.35%)
    22 / 9108 (0.24%)
    25 / 9109 (0.27%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 22
    0 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Prerenal failure
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basedow's disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic nodular goitre
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle atrophy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    5 / 9135 (0.05%)
    8 / 9108 (0.09%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthropathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 9135 (0.00%)
    4 / 9108 (0.04%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scoliosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal stiffness
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seronegative arthritis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal synovial cyst
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess oral
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    4 / 9135 (0.04%)
    1 / 9108 (0.01%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    3 / 9135 (0.03%)
    3 / 9108 (0.03%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cellulitis
         subjects affected / exposed
    11 / 9135 (0.12%)
    9 / 9108 (0.10%)
    11 / 9109 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    7 / 9135 (0.08%)
    3 / 9108 (0.03%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis infected
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear lobe infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Folliculitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fournier's gangrene
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    4 / 9135 (0.04%)
    6 / 9108 (0.07%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 9135 (0.05%)
    5 / 9108 (0.05%)
    6 / 9109 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    4 / 9135 (0.04%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Meningitis aseptic
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    19 / 9135 (0.21%)
    28 / 9108 (0.31%)
    27 / 9109 (0.30%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 28
    0 / 32
         deaths causally related to treatment / all
    0 / 13
    0 / 16
    0 / 17
    Pharyngitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    3 / 9135 (0.03%)
    3 / 9108 (0.03%)
    4 / 9109 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 9135 (0.03%)
    3 / 9108 (0.03%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    22 / 9135 (0.24%)
    19 / 9108 (0.21%)
    18 / 9109 (0.20%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 19
    0 / 18
         deaths causally related to treatment / all
    0 / 13
    0 / 11
    0 / 8
    Skin infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    4 / 9135 (0.04%)
    9 / 9108 (0.10%)
    8 / 9109 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 8
    0 / 5
    Subcutaneous abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    18 / 9135 (0.20%)
    11 / 9108 (0.12%)
    17 / 9109 (0.19%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 11
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral myocarditis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 9135 (0.02%)
    9 / 9108 (0.10%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    11 / 9135 (0.12%)
    9 / 9108 (0.10%)
    7 / 9109 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Anal abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal abscess
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    2 / 9135 (0.02%)
    3 / 9108 (0.03%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Neuroborreliosis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    3 / 9108 (0.03%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Biliary sepsis
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Wound sepsis
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral toxoplasmosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    2 / 9108 (0.02%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Intervertebral discitis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Borrelia infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical mycobacterial infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mycobacterial infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Keratitis bacterial
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    2 / 9108 (0.02%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection bacterial
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    3 / 9135 (0.03%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial abdominal infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    Nephritis bacterial
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    5 / 9135 (0.05%)
    6 / 9108 (0.07%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 9135 (0.01%)
    5 / 9108 (0.05%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    4 / 9135 (0.04%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    2 / 9109 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Fluid overload
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 9135 (0.01%)
    1 / 9108 (0.01%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperammonaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 9135 (0.03%)
    1 / 9108 (0.01%)
    3 / 9109 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Hypomagnesaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    2 / 9135 (0.02%)
    1 / 9108 (0.01%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 9135 (0.01%)
    3 / 9108 (0.03%)
    5 / 9109 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 9135 (0.00%)
    1 / 9108 (0.01%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic complication
         subjects affected / exposed
    0 / 9135 (0.00%)
    0 / 9108 (0.00%)
    1 / 9109 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Marasmus
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 9135 (0.01%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    2 / 9135 (0.02%)
    0 / 9108 (0.00%)
    0 / 9109 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 Rivaroxaban 2.5mg + Aspirin 100mg Rivaroxaban Placebo + Aspirin 100mg Rivaroxaban 5mg + Aspirin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    569 / 9135 (6.23%)
    526 / 9108 (5.78%)
    540 / 9109 (5.93%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    25 / 9135 (0.27%)
    12 / 9108 (0.13%)
    16 / 9109 (0.18%)
         occurrences all number
    25
    13
    18
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    5 / 9135 (0.05%)
    10 / 9108 (0.11%)
    3 / 9109 (0.03%)
         occurrences all number
    5
    10
    4
    Pyrexia
         subjects affected / exposed
    6 / 9135 (0.07%)
    8 / 9108 (0.09%)
    10 / 9109 (0.11%)
         occurrences all number
    6
    9
    10
    Oedema peripheral
         subjects affected / exposed
    3 / 9135 (0.03%)
    12 / 9108 (0.13%)
    7 / 9109 (0.08%)
         occurrences all number
    7
    15
    8
    Chest pain
         subjects affected / exposed
    7 / 9135 (0.08%)
    10 / 9108 (0.11%)
    9 / 9109 (0.10%)
         occurrences all number
    11
    10
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 9135 (0.08%)
    11 / 9108 (0.12%)
    12 / 9109 (0.13%)
         occurrences all number
    9
    13
    18
    Epistaxis
         subjects affected / exposed
    38 / 9135 (0.42%)
    25 / 9108 (0.27%)
    29 / 9109 (0.32%)
         occurrences all number
    73
    30
    45
    Haemoptysis
         subjects affected / exposed
    10 / 9135 (0.11%)
    5 / 9108 (0.05%)
    5 / 9109 (0.05%)
         occurrences all number
    25
    5
    6
    Upper respiratory tract inflammation
         subjects affected / exposed
    10 / 9135 (0.11%)
    4 / 9108 (0.04%)
    8 / 9109 (0.09%)
         occurrences all number
    11
    4
    9
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    7 / 9135 (0.08%)
    4 / 9108 (0.04%)
    12 / 9109 (0.13%)
         occurrences all number
    8
    4
    14
    Investigations
    Occult blood positive
         subjects affected / exposed
    12 / 9135 (0.13%)
    3 / 9108 (0.03%)
    7 / 9109 (0.08%)
         occurrences all number
    12
    4
    7
    Injury, poisoning and procedural complications
    Skin abrasion
         subjects affected / exposed
    11 / 9135 (0.12%)
    3 / 9108 (0.03%)
    4 / 9109 (0.04%)
         occurrences all number
    12
    3
    4
    Contusion
         subjects affected / exposed
    37 / 9135 (0.41%)
    28 / 9108 (0.31%)
    23 / 9109 (0.25%)
         occurrences all number
    42
    43
    27
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    26 / 9135 (0.28%)
    22 / 9108 (0.24%)
    19 / 9109 (0.21%)
         occurrences all number
    44
    33
    34
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    25 / 9135 (0.27%)
    36 / 9108 (0.40%)
    26 / 9109 (0.29%)
         occurrences all number
    41
    43
    38
    Headache
         subjects affected / exposed
    21 / 9135 (0.23%)
    23 / 9108 (0.25%)
    21 / 9109 (0.23%)
         occurrences all number
    32
    33
    32
    Hypoaesthesia
         subjects affected / exposed
    7 / 9135 (0.08%)
    12 / 9108 (0.13%)
    8 / 9109 (0.09%)
         occurrences all number
    7
    15
    9
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    8 / 9135 (0.09%)
    1 / 9108 (0.01%)
    12 / 9109 (0.13%)
         occurrences all number
    10
    1
    16
    Anaemia
         subjects affected / exposed
    16 / 9135 (0.18%)
    10 / 9108 (0.11%)
    12 / 9109 (0.13%)
         occurrences all number
    27
    13
    14
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    10 / 9135 (0.11%)
    15 / 9108 (0.16%)
    13 / 9109 (0.14%)
         occurrences all number
    13
    19
    19
    Eye disorders
    Cataract
         subjects affected / exposed
    12 / 9135 (0.13%)
    12 / 9108 (0.13%)
    15 / 9109 (0.16%)
         occurrences all number
    12
    13
    16
    Conjunctival haemorrhage
         subjects affected / exposed
    10 / 9135 (0.11%)
    3 / 9108 (0.03%)
    11 / 9109 (0.12%)
         occurrences all number
    13
    3
    14
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    18 / 9135 (0.20%)
    11 / 9108 (0.12%)
    11 / 9109 (0.12%)
         occurrences all number
    33
    20
    22
    Diarrhoea
         subjects affected / exposed
    48 / 9135 (0.53%)
    31 / 9108 (0.34%)
    58 / 9109 (0.64%)
         occurrences all number
    65
    39
    79
    Abdominal pain
         subjects affected / exposed
    8 / 9135 (0.09%)
    3 / 9108 (0.03%)
    12 / 9109 (0.13%)
         occurrences all number
    12
    3
    23
    Abdominal pain upper
         subjects affected / exposed
    31 / 9135 (0.34%)
    22 / 9108 (0.24%)
    19 / 9109 (0.21%)
         occurrences all number
    48
    30
    32
    Dental caries
         subjects affected / exposed
    15 / 9135 (0.16%)
    10 / 9108 (0.11%)
    12 / 9109 (0.13%)
         occurrences all number
    15
    10
    13
    Gastritis
         subjects affected / exposed
    19 / 9135 (0.21%)
    13 / 9108 (0.14%)
    7 / 9109 (0.08%)
         occurrences all number
    28
    21
    7
    Constipation
         subjects affected / exposed
    26 / 9135 (0.28%)
    24 / 9108 (0.26%)
    18 / 9109 (0.20%)
         occurrences all number
    33
    37
    20
    Nausea
         subjects affected / exposed
    21 / 9135 (0.23%)
    17 / 9108 (0.19%)
    18 / 9109 (0.20%)
         occurrences all number
    30
    25
    28
    Dyspepsia
         subjects affected / exposed
    14 / 9135 (0.15%)
    15 / 9108 (0.16%)
    13 / 9109 (0.14%)
         occurrences all number
    19
    24
    22
    Large intestine polyp
         subjects affected / exposed
    17 / 9135 (0.19%)
    8 / 9108 (0.09%)
    12 / 9109 (0.13%)
         occurrences all number
    18
    8
    14
    Vomiting
         subjects affected / exposed
    8 / 9135 (0.09%)
    11 / 9108 (0.12%)
    8 / 9109 (0.09%)
         occurrences all number
    9
    14
    9
    Gingival bleeding
         subjects affected / exposed
    11 / 9135 (0.12%)
    6 / 9108 (0.07%)
    11 / 9109 (0.12%)
         occurrences all number
    13
    7
    13
    Stomatitis
         subjects affected / exposed
    12 / 9135 (0.13%)
    4 / 9108 (0.04%)
    12 / 9109 (0.13%)
         occurrences all number
    12
    4
    12
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    17 / 9135 (0.19%)
    20 / 9108 (0.22%)
    19 / 9109 (0.21%)
         occurrences all number
    23
    22
    25
    Haemorrhage subcutaneous
         subjects affected / exposed
    49 / 9135 (0.54%)
    17 / 9108 (0.19%)
    18 / 9109 (0.20%)
         occurrences all number
    86
    29
    23
    Pruritus
         subjects affected / exposed
    19 / 9135 (0.21%)
    18 / 9108 (0.20%)
    23 / 9109 (0.25%)
         occurrences all number
    27
    22
    37
    Urticaria
         subjects affected / exposed
    11 / 9135 (0.12%)
    6 / 9108 (0.07%)
    11 / 9109 (0.12%)
         occurrences all number
    13
    7
    11
    Rash
         subjects affected / exposed
    12 / 9135 (0.13%)
    19 / 9108 (0.21%)
    18 / 9109 (0.20%)
         occurrences all number
    22
    31
    33
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    24 / 9135 (0.26%)
    8 / 9108 (0.09%)
    15 / 9109 (0.16%)
         occurrences all number
    34
    10
    25
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    28 / 9135 (0.31%)
    30 / 9108 (0.33%)
    26 / 9109 (0.29%)
         occurrences all number
    32
    36
    31
    Back pain
         subjects affected / exposed
    25 / 9135 (0.27%)
    25 / 9108 (0.27%)
    37 / 9109 (0.41%)
         occurrences all number
    27
    27
    39
    Lumbar spinal stenosis
         subjects affected / exposed
    10 / 9135 (0.11%)
    6 / 9108 (0.07%)
    5 / 9109 (0.05%)
         occurrences all number
    10
    6
    5
    Myalgia
         subjects affected / exposed
    6 / 9135 (0.07%)
    13 / 9108 (0.14%)
    14 / 9109 (0.15%)
         occurrences all number
    7
    14
    18
    Spinal osteoarthritis
         subjects affected / exposed
    10 / 9135 (0.11%)
    8 / 9108 (0.09%)
    7 / 9109 (0.08%)
         occurrences all number
    10
    8
    7
    Osteoarthritis
         subjects affected / exposed
    5 / 9135 (0.05%)
    8 / 9108 (0.09%)
    10 / 9109 (0.11%)
         occurrences all number
    7
    10
    10
    Pain in extremity
         subjects affected / exposed
    14 / 9135 (0.15%)
    9 / 9108 (0.10%)
    8 / 9109 (0.09%)
         occurrences all number
    19
    12
    10
    Muscle spasms
         subjects affected / exposed
    10 / 9135 (0.11%)
    6 / 9108 (0.07%)
    10 / 9109 (0.11%)
         occurrences all number
    11
    9
    12
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    188 / 9135 (2.06%)
    195 / 9108 (2.14%)
    181 / 9109 (1.99%)
         occurrences all number
    284
    289
    284
    Herpes zoster
         subjects affected / exposed
    9 / 9135 (0.10%)
    19 / 9108 (0.21%)
    15 / 9109 (0.16%)
         occurrences all number
    9
    21
    15
    Gastroenteritis
         subjects affected / exposed
    16 / 9135 (0.18%)
    10 / 9108 (0.11%)
    10 / 9109 (0.11%)
         occurrences all number
    21
    11
    10
    Bronchitis
         subjects affected / exposed
    14 / 9135 (0.15%)
    13 / 9108 (0.14%)
    7 / 9109 (0.08%)
         occurrences all number
    15
    13
    7
    Cystitis
         subjects affected / exposed
    6 / 9135 (0.07%)
    7 / 9108 (0.08%)
    10 / 9109 (0.11%)
         occurrences all number
    6
    7
    13
    Influenza
         subjects affected / exposed
    18 / 9135 (0.20%)
    24 / 9108 (0.26%)
    14 / 9109 (0.15%)
         occurrences all number
    18
    25
    16
    Periodontitis
         subjects affected / exposed
    12 / 9135 (0.13%)
    12 / 9108 (0.13%)
    11 / 9109 (0.12%)
         occurrences all number
    13
    12
    11
    Pharyngitis
         subjects affected / exposed
    8 / 9135 (0.09%)
    10 / 9108 (0.11%)
    7 / 9109 (0.08%)
         occurrences all number
    8
    11
    7
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    26 / 9135 (0.28%)
    28 / 9108 (0.31%)
    16 / 9109 (0.18%)
         occurrences all number
    27
    28
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jul 2014
    Amendment 6 formed integrated protocol version 2.0. The major modifications specified in Amendment 6 were simplified and clarified eligibility criteria for the study population of subjects with CAD and PAD and an increase of the sample size from 19500 to ~21400 randomized subjects.
    19 Aug 2015
    Amendment 8 formed integrated protocol version 3.0. The main modification due to Amendment 8 was a modification of the secondary outcomes to include 2 new composites of major thrombotic events, including new outcome components (ALI and CHD death). The multiple testing strategy was revised to ensure the control of the familywise type I error for both testing of primary and secondary efficacy variables for the final analyses based on 2200 events. The statistical analysis plan (SAP) was updated according to the advice received by the Food and Drug Administration (FDA) in the letter received in AUG 2014: the description for the analysis in the case where only 1 of the 2 interventional arms is continued after an interim analysis. Furthermore, the number of subjects in the trial was increased to at least 27400 randomized subjects.
    12 Sep 2017
    Amendment 11 formed integrated protocol version 4.0. The main modification due to Amendment 11 was the addition of the COMPASS LTOLE phase to make rivaroxaban 2.5 mg bid plus aspirin 100 mg od available to the study subjects prior to commercial availability. For this purpose, a final rivaroxaban/aspirin follow-up visit and a rivaroxaban/aspirin washout visit was introduced while the pantoprazole treatment continued.

    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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