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    Clinical Trial Results:
    An international, multicenter, randomized, double-blind, placebo-controlled phase 3 trial investigating the efficacy and safety of rivaroxaban to reduce the risk of major thrombotic vascular events in patients with symptomatic peripheral artery disease undergoing lower extremity revascularization procedures

    Summary
    EudraCT number
    		 2014-005569-58
    Trial protocol
    		 CZ   AT   ES   HU   GB   FR   PT   SE   BE   BG   DK   DE   NL   PL   SK   LT   LV   RO   EE   FI   IT  
    Global end of trial date
    09 Jan 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Nov 2020
    First version publication date
    26 Nov 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    17454
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02504216
    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, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, 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
    31 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective of the study was: - to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducing the risk of major thrombotic vascular events (defined as MI, ischemic stroke, CV (Cardiovascular) death, ALI (Acute limb ischemia), and major amputation of a vascular etiology) in symptomatic PAD (Peripheral artery disease) patients with a recent lower extremity revascularization procedure. The primary safety objective of the study was: - to evaluate the overall safety and tolerability of rivaroxaban added to ASA compared to ASA alone.
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 287
    Country: Number of subjects enrolled
    Japan: 459
    Country: Number of subjects enrolled
    Korea, Republic of: 148
    Country: Number of subjects enrolled
    Bulgaria: 737
    Country: Number of subjects enrolled
    Czechia: 243
    Country: Number of subjects enrolled
    Estonia: 9
    Country: Number of subjects enrolled
    Hungary: 261
    Country: Number of subjects enrolled
    Latvia: 202
    Country: Number of subjects enrolled
    Lithuania: 84
    Country: Number of subjects enrolled
    Poland: 168
    Country: Number of subjects enrolled
    Romania: 214
    Country: Number of subjects enrolled
    Russian Federation: 188
    Country: Number of subjects enrolled
    Serbia: 68
    Country: Number of subjects enrolled
    Slovakia: 126
    Country: Number of subjects enrolled
    Ukraine: 299
    Country: Number of subjects enrolled
    Canada: 170
    Country: Number of subjects enrolled
    United States: 524
    Country: Number of subjects enrolled
    Argentina: 299
    Country: Number of subjects enrolled
    Brazil: 185
    Country: Number of subjects enrolled
    Austria: 212
    Country: Number of subjects enrolled
    Belgium: 126
    Country: Number of subjects enrolled
    Denmark: 78
    Country: Number of subjects enrolled
    Thailand: 67
    Country: Number of subjects enrolled
    Finland: 17
    Country: Number of subjects enrolled
    France: 107
    Country: Number of subjects enrolled
    Germany: 593
    Country: Number of subjects enrolled
    Italy: 184
    Country: Number of subjects enrolled
    Netherlands: 77
    Country: Number of subjects enrolled
    Portugal: 74
    Country: Number of subjects enrolled
    Spain: 96
    Country: Number of subjects enrolled
    Sweden: 42
    Country: Number of subjects enrolled
    Switzerland: 91
    Country: Number of subjects enrolled
    United Kingdom: 129
    Worldwide total number of subjects
    6564
    EEA total number of subjects
    3779
    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)
    2622
    From 65 to 84 years
    3801
    85 years and over
    141

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 548 centers which screened subjects (534 sites randomized subjects) world-wide between 31 Jul 2015 (first patient’s first visit) and 27 Nov 2019 (last patient’s last visit).

    Pre-assignment
    Screening details
    		 A total of 6772 subjects were screened, of which 6564 were randomly assigned to either of the two treatment arms.

    Period 1
    Period 1 title
    Overall (overall period)
    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 2.5 mg bid + Aspirin 100 mg od
    Arm description
    		 Subjects were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Acetylsalicylic Acid (ASA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg once-daily (od)

    Investigational medicinal product name
    Rivaroxaban (Xarelto, BAY59-7939)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg twice-daily (bid) (5 mg/day)

    Arm title
    		 Rivaroxaban placebo bid + Aspirin 100 mg od
    Arm description
    		 Subjects were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Acetylsalicylic Acid (ASA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg once-daily (od)

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

    Number of subjects in period 1
    		Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Started
    3286
    3278
    Received treatment
    3256 [1]
    3248 [2]
    Completed
    3275
    3263
    Not completed
    11
    15
         Consent withdrawn by subject
    8
    12
         Lost to follow-up
    3
    3
    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: 30 subjects were never administered study drug.
    [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: 30 subjects were never administered study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od
    Reporting group description
    		 Subjects were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)

    Reporting group title
    Rivaroxaban placebo bid + Aspirin 100 mg od
    Reporting group description
    		 Subjects were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily

    Reporting group values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od Total
    Number of subjects
    		 3286 3278 6564
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        median (full range (min-max))
    		 67.0 (49 to 93) 67.0 (50 to 95) -
    Gender Categorical
    Units: Subjects
        Female
    		 847 857 1704
        Male
    		 2439 2421 4860
    Race
    Units: Subjects
        White
    		 2647 2656 5303
        Black or African American
    		 84 71 155
        Asian
    		 484 482 966
        American Indian or Alaska native
    		 1 4 5
        Native Hawaiian or other Pacific islander
    		 0 1 1
        Not reported
    		 69 62 131
        Multiple
    		 1 2 3

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od
    Reporting group description
    		 Subjects were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)

    Reporting group title
    Rivaroxaban placebo bid + Aspirin 100 mg od
    Reporting group description
    		 Subjects were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily

    Subject analysis set title
    Intention-to-treat analysis set (ITT Set)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT population comprised all randomized subjects.

    Subject analysis set title
    Safety analysis set (SAF Set)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The SAF comprised all treated subjects, i.e. randomized subjects who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).

    Primary: Primary efficacy outcome: Composite of Myocardial infarction (MI), ischemic stroke, cardiovascular death, acute limb ischemia (ALI) and major amputation due to a vascular etiology

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    End point title
    		 Primary efficacy outcome: Composite of Myocardial infarction (MI), ischemic stroke, cardiovascular death, acute limb ischemia (ALI) and major amputation due to a vascular etiology
    End point description
    Only the first occurrence of the outcome event under analysis within the data scope from a subject is considered.
    End point type
    Primary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    508
    584
    Statistical analysis title
    		 Primary efficacy outcome
    Comparison groups
    Rivaroxaban placebo bid + Aspirin 100 mg od v Rivaroxaban 2.5 mg bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0043 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 0.96
    Notes
    [1] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS (Interactive web/voice response system) assignment with treatment as a factor.

    Primary: Primary safety outcome: Number of participants with TIMI Major bleeding

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    End point title
    		 Primary safety outcome: Number of participants with TIMI Major bleeding
    End point description
    TIMI: Thrombolysis in Myocardial Infarction Only the first occurrence of the outcome event under analysis within the data scope from a subject is considered.
    End point type
    Primary
    End point timeframe
    For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3256
    3248
    Units: Subject
    62
    44
    Statistical analysis title
    		 TIMI major bleeding
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6504
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0695 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.1
    Notes
    [2] - P−value (2-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Composite of MI, ischemic stroke, Coronary heart disease (CHD) death, ALI, and major amputation of a vascular etiology

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    End point title
    		 Composite of MI, ischemic stroke, Coronary heart disease (CHD) death, ALI, and major amputation of a vascular etiology
    End point description
    MI, stroke, mortality, ALI, and major amputation of a vascular etiology, and events leading to hospitalization are adjudicated.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    433
    528
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.91
    Notes
    [3] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Number of participants with an unplanned index limb revascularization for recurrent limb ischemia (subsequent index leg revascularization that was not planned or considered as part of the initial treatment plan at the time of randomization)

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    End point title
    		 Number of participants with an unplanned index limb revascularization for recurrent limb ischemia (subsequent index leg revascularization that was not planned or considered as part of the initial treatment plan at the time of randomization)
    End point description
    Index limb revascularization is defined as subsequent index leg revascularization that was not planned or considered as part of the initial treatment plan at the time of randomization. index limb revascularization were reported by investigator only.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    584
    655
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.014 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 0.99
    Notes
    [4] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Number of participants with hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature

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    End point title
    		 Number of participants with hospitalization for a coronary or peripheral cause (either lower limb) of a thrombotic nature
    End point description
    Events leading to hospitalization are adjudicated.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    262
    356
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.85
    Notes
    [5] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Composite of MI, ischemic stroke, All-cause mortality (ACM), ALI, and major amputation of a vascular etiology

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    End point title
    		 Composite of MI, ischemic stroke, All-cause mortality (ACM), ALI, and major amputation of a vascular etiology
    End point description
    MI, stroke, mortality, ALI, and major amputation of a vascular etiology are adjudicated.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    614
    679
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0145 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 0.99
    Notes
    [6] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Composite of MI, all-cause stroke, Cardiovascular (CV) death, Acute limb ischemia (ALI), and major amputation of a vascular etiology

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    End point title
    		 Composite of MI, all-cause stroke, Cardiovascular (CV) death, Acute limb ischemia (ALI), and major amputation of a vascular etiology
    End point description
    MI, stroke, mortality, ALI, and major amputation of a vascular etiology are adjudicated.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    514
    588
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051 [7]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 0.96
    Notes
    [7] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Mortality (all-cause)

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    End point title
    		 Mortality (all-cause)
    End point description
    Mortality are adjudicated.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 days
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    321
    297
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8322 [8]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.27
    Notes
    [8] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Number of participants with venous thromboembolic (VTE) events

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    End point title
    		 Number of participants with venous thromboembolic (VTE) events
    End point description
    Venous thromboembolic events were reported by investigator only.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 days
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3286
    3278
    Units: Subject
    25
    41
    Statistical analysis title
    		 Secondary efficacy outcome
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6564
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0235 [9]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1
    Notes
    [9] - P-value (1-sided) is based on the log rank test stratified by type of procedure and clopidogrel use per IxRS assignment with treatment as a factor.

    Secondary: Secondary safety outcome: Number of participants with ISTH major bleeding

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    End point title
    		 Secondary safety outcome: Number of participants with ISTH major bleeding
    End point description
    ISTH: International Society on Thrombosis and Haemostasis Only the first occurrence of the outcome event under analysis within the data scope from a subject is considered.
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3256
    3248
    Units: Subject
    140
    100
    Statistical analysis title
    		 ISTH major bleeding
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6504
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0068
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.84

    Secondary: Secondary safety outcome: Number of participants with BARC Type 3b and above bleeding events

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    End point title
    		 Secondary safety outcome: Number of participants with BARC Type 3b and above bleeding events
    End point description
    BARC: Bleeding Academic Research Consortium Only the first occurrence of the outcome event under analysis within the data scope from a subject is considered
    End point type
    Secondary
    End point timeframe
    For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)
    End point values
    		 Rivaroxaban 2.5 mg bid + Aspirin 100 mg od Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects analysed
    3256
    3248
    Units: Subject
    93
    73
    Statistical analysis title
    		 BARC Type 3b and above bleeding events
    Comparison groups
    Rivaroxaban 2.5 mg bid + Aspirin 100 mg od v Rivaroxaban placebo bid + Aspirin 100 mg od
    Number of subjects included in analysis
    6504
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0979
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.76

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization until 2 days following permanent discontinuation of the study drug
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Rivaroxaban 2.5 mg bid + ASA 100 mg od
    Reporting group description
    		 Subjects were treated with Rivaroxaban 2.5 mg twice-daily (bid) and ASA (Acetylsalicylic Acid) 100 mg once-daily (od)

    Reporting group title
    Rivaroxaban placebo bid + ASA 100 mg od
    Reporting group description
    		 Subjects were treated with Rivaroxaban-placebo twice-daily and ASA (Acetylsalicylic Acid) 100 mg once-daily

    Serious adverse events
    		 Rivaroxaban 2.5 mg bid + ASA 100 mg od Rivaroxaban placebo bid + ASA 100 mg od
    Total subjects affected by serious adverse events
         subjects affected / exposed
    948 / 3256 (29.12%)
    927 / 3248 (28.54%)
         number of deaths (all causes)
    327
    304
         number of deaths resulting from adverse events
    76
    79
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Basal cell carcinoma
         subjects affected / exposed
    3 / 3256 (0.09%)
    7 / 3248 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign laryngeal neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of skin
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    4 / 3256 (0.12%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer stage IV
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder neoplasm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lymphoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon cancer
         subjects affected / exposed
    5 / 3256 (0.15%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    5 / 3256 (0.15%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric cancer stage I
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer stage II
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung adenocarcinoma recurrent
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung squamous cell carcinoma stage IV
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    3 / 3256 (0.09%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to lung
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to neck
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Neoplasm skin
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma recurrent
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Papillary serous endometrial carcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal cancer
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal cancer stage I
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer stage IV
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell carcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 3256 (0.09%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Salivary gland adenoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    8 / 3256 (0.25%)
    14 / 3248 (0.43%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 16
         deaths causally related to treatment / all
    0 / 4
    0 / 7
    Metastases to central nervous system
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    9 / 3256 (0.28%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymoma malignant
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal cancer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract neoplasm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lip and/or oral cavity cancer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's disease stage IV
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    4 / 3256 (0.12%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Rectal neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gingival cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head and neck cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory pseudotumour
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenolymphoma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic cancer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant genitourinary tract neoplasm
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm papilla of Vater
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal adenocarcinoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin squamous cell carcinoma recurrent
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    6 / 3256 (0.18%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 3256 (0.03%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    5 / 3256 (0.15%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 3256 (0.12%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    43 / 3256 (1.32%)
    52 / 3248 (1.60%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral coldness
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    34 / 3256 (1.04%)
    29 / 3248 (0.89%)
         occurrences causally related to treatment / all
    0 / 44
    1 / 46
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    3 / 3256 (0.09%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poor peripheral circulation
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renovascular hypertension
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    2 / 3256 (0.06%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphorrhoea
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    7 / 3256 (0.21%)
    9 / 3248 (0.28%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous occlusion
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    12 / 3256 (0.37%)
    8 / 3248 (0.25%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    125 / 3256 (3.84%)
    130 / 3248 (4.00%)
         occurrences causally related to treatment / all
    1 / 156
    0 / 182
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic limb pain
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    0 / 3256 (0.00%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    25 / 3256 (0.77%)
    14 / 3248 (0.43%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Bladder calculus removal
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blepharoplasty
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot amputation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia repair
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitrectomy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radical prostatectomy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus management
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral bladder resection
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral revascularisation
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain tumour operation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoprostatectomy
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amputation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder polypectomy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm surgery
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb reconstructive surgery
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery bypass
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stent insertion
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eventration repair
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crepitations
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    3 / 3256 (0.09%)
    7 / 3248 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture site haemorrhage
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Organ failure
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    3 / 3256 (0.09%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    11 / 3256 (0.34%)
    8 / 3248 (0.25%)
         occurrences causally related to treatment / all
    2 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Vascular device occlusion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Disease risk factor
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spermatocele
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvar dysplasia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval eczema
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    2 / 3256 (0.06%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aspiration
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    16 / 3256 (0.49%)
    9 / 3248 (0.28%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 3256 (0.12%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 3256 (0.09%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    5 / 3256 (0.15%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pneumothorax
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    5 / 3256 (0.15%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Sinus polyp
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal lesion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar cyst
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic respiratory disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute interstitial pneumonitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    4 / 3256 (0.12%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Depression
         subjects affected / exposed
    3 / 3256 (0.09%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organic brain syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient psychosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patient-device incompatibility
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device battery issue
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    7 / 3256 (0.21%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    2 / 3256 (0.06%)
    12 / 3248 (0.37%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    0 / 3256 (0.00%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Steatohepatitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary biliary cholangitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular function test abnormal
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoscopy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunoglobulins decreased
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbohydrate antigen 19-9 increased
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular test
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    2 / 3256 (0.06%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain herniation
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to anastomose
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    4 / 3256 (0.12%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    10 / 3256 (0.31%)
    12 / 3248 (0.37%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    5 / 3256 (0.15%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intentional overdose
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating abdominal trauma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic ulcer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post laminectomy syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Underdose
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural discharge
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chemical burn of skin
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural oedema
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    5 / 3256 (0.15%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral hyperperfusion syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal anastomotic leak
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial reocclusion
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    16 / 3256 (0.49%)
    15 / 3248 (0.46%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin scar contracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft stenosis
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft restenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site haematoma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass thrombosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass occlusion
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass stenosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital bladder neck obstruction
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomatous polyposis coli
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    10 / 3256 (0.31%)
    10 / 3248 (0.31%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    3 / 3256 (0.09%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    19 / 3256 (0.58%)
    20 / 3248 (0.62%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    14 / 3256 (0.43%)
    14 / 3248 (0.43%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac failure acute
         subjects affected / exposed
    3 / 3256 (0.09%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    6 / 3256 (0.18%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    10 / 3256 (0.31%)
    8 / 3248 (0.25%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    15 / 3256 (0.46%)
    21 / 3248 (0.65%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 21
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyanosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pericarditis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachyarrhythmia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    22 / 3256 (0.68%)
    24 / 3248 (0.74%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral atrophy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    5 / 3256 (0.15%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drop attacks
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental impairment
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Syncope
         subjects affected / exposed
    9 / 3256 (0.28%)
    11 / 3248 (0.34%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tension headache
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic convulsion
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic neuropathy
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Putamen haemorrhage
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve disorder
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Parkinson's disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudoradicular syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colloid brain cyst
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacral radiculopathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    14 / 3256 (0.43%)
    10 / 3248 (0.31%)
         occurrences causally related to treatment / all
    10 / 16
    4 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 3256 (0.12%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    8 / 3256 (0.25%)
    8 / 3248 (0.25%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract subcapsular
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Detachment of macular retinal pigment epithelium
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreoretinal traction syndrome
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular detachment
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dental alveolar anomaly
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry mouth
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    3 / 3256 (0.09%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gallstone ileus
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    3 / 3256 (0.09%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 3256 (0.09%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal necrosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    4 / 3256 (0.12%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal angina
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Intestinal obstruction
         subjects affected / exposed
    3 / 3256 (0.09%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ulcer
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    4 / 3256 (0.12%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 3256 (0.00%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontal disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 3256 (0.00%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth loss
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric antral vascular ectasia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    10 / 3256 (0.31%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic duct stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis contact
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hidradenitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigus
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin exfoliation
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    10 / 3256 (0.31%)
    12 / 3248 (0.37%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    9 / 3256 (0.28%)
    9 / 3248 (0.28%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug reaction with eosinophilia and systemic symptoms
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic skin ulcer
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myxoid cyst
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus bladder
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    4 / 3256 (0.12%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    6 / 3256 (0.18%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ureteric fistula
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    3 / 3256 (0.09%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    9 / 3256 (0.28%)
    17 / 3248 (0.52%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    End stage renal disease
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone disorder
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone formation increased
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture nonunion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw cyst
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    3 / 3256 (0.09%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metatarsalgia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle disorder
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    14 / 3256 (0.43%)
    13 / 3248 (0.40%)
         occurrences causally related to treatment / all
    2 / 18
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    6 / 3256 (0.18%)
    14 / 3248 (0.43%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon disorder
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    6 / 3256 (0.18%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral column mass
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired claw toe
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament disorder
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue disorder
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone loss
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue necrosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic scleroderma
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    6 / 3256 (0.18%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    4 / 3256 (0.12%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerotic gangrene
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blister infected
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    19 / 3256 (0.58%)
    18 / 3248 (0.55%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis gangrenous
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 3256 (0.06%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    4 / 3256 (0.12%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 3256 (0.03%)
    10 / 3248 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fournier's gangrene
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal cystitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal skin infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    16 / 3256 (0.49%)
    20 / 3248 (0.62%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    6 / 3256 (0.18%)
    4 / 3248 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    19 / 3256 (0.58%)
    11 / 3248 (0.34%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    11 / 3256 (0.34%)
    12 / 3248 (0.37%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    3 / 3256 (0.09%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric abscess
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    40 / 3256 (1.23%)
    45 / 3248 (1.39%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 50
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Postoperative wound infection
         subjects affected / exposed
    27 / 3256 (0.83%)
    25 / 3248 (0.77%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    12 / 3256 (0.37%)
    13 / 3248 (0.40%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Septic shock
         subjects affected / exposed
    1 / 3256 (0.03%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Sinusitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    13 / 3256 (0.40%)
    11 / 3248 (0.34%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    17 / 3256 (0.52%)
    15 / 3248 (0.46%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 3256 (0.00%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Scrotal abscess
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    3 / 3256 (0.09%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    6 / 3256 (0.18%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lymph gland infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periumbilical abscess
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burn infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 3256 (0.03%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Perineal abscess
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric infection
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    3 / 3256 (0.09%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    2 / 3256 (0.06%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural abscess
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    2 / 3256 (0.06%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis bacterial
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection bacterial
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected seroma
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    0 / 3256 (0.00%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal cellulitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular device infection
         subjects affected / exposed
    2 / 3256 (0.06%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    6 / 3256 (0.18%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    6 / 3256 (0.18%)
    8 / 3248 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 3256 (0.06%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    3 / 3248 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    3 / 3256 (0.09%)
    6 / 3248 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    3 / 3256 (0.09%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 3256 (0.03%)
    0 / 3248 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 3256 (0.00%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 3256 (0.00%)
    2 / 3248 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 3256 (0.09%)
    5 / 3248 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 3256 (0.03%)
    1 / 3248 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.1%
    Non-serious adverse events
    		 Rivaroxaban 2.5 mg bid + ASA 100 mg od Rivaroxaban placebo bid + ASA 100 mg od
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    725 / 3256 (22.27%)
    729 / 3248 (22.44%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences all number
    1
    4
    Vascular disorders
    Hypertension
         subjects affected / exposed
    49 / 3256 (1.50%)
    50 / 3248 (1.54%)
         occurrences all number
    54
    56
    Hypotension
         subjects affected / exposed
    7 / 3256 (0.21%)
    3 / 3248 (0.09%)
         occurrences all number
    7
    3
    Hypertensive crisis
         subjects affected / exposed
    11 / 3256 (0.34%)
    13 / 3248 (0.40%)
         occurrences all number
    13
    15
    Peripheral ischaemia
         subjects affected / exposed
    3 / 3256 (0.09%)
    11 / 3248 (0.34%)
         occurrences all number
    3
    14
    Intermittent claudication
         subjects affected / exposed
    39 / 3256 (1.20%)
    43 / 3248 (1.32%)
         occurrences all number
    48
    48
    Peripheral vascular disorder
         subjects affected / exposed
    6 / 3256 (0.18%)
    5 / 3248 (0.15%)
         occurrences all number
    8
    5
    Dry gangrene
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences all number
    1
    4
    Peripheral artery occlusion
         subjects affected / exposed
    6 / 3256 (0.18%)
    12 / 3248 (0.37%)
         occurrences all number
    6
    13
    Extremity necrosis
         subjects affected / exposed
    6 / 3256 (0.18%)
    5 / 3248 (0.15%)
         occurrences all number
    7
    5
    Peripheral arterial occlusive disease
         subjects affected / exposed
    34 / 3256 (1.04%)
    31 / 3248 (0.95%)
         occurrences all number
    45
    37
    Peripheral artery stenosis
         subjects affected / exposed
    13 / 3256 (0.40%)
    10 / 3248 (0.31%)
         occurrences all number
    16
    13
    Surgical and medical procedures
    Tooth extraction
         subjects affected / exposed
    6 / 3256 (0.18%)
    5 / 3248 (0.15%)
         occurrences all number
    7
    5
    Cataract operation
         subjects affected / exposed
    5 / 3256 (0.15%)
    8 / 3248 (0.25%)
         occurrences all number
    6
    10
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 3256 (0.18%)
    4 / 3248 (0.12%)
         occurrences all number
    6
    4
    Chest discomfort
         subjects affected / exposed
    6 / 3256 (0.18%)
    1 / 3248 (0.03%)
         occurrences all number
    6
    1
    Chest pain
         subjects affected / exposed
    11 / 3256 (0.34%)
    16 / 3248 (0.49%)
         occurrences all number
    12
    16
    Fatigue
         subjects affected / exposed
    11 / 3256 (0.34%)
    12 / 3248 (0.37%)
         occurrences all number
    11
    14
    Gait disturbance
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    5
    2
    Impaired healing
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences all number
    4
    2
    Oedema peripheral
         subjects affected / exposed
    16 / 3256 (0.49%)
    20 / 3248 (0.62%)
         occurrences all number
    17
    21
    Peripheral swelling
         subjects affected / exposed
    9 / 3256 (0.28%)
    10 / 3248 (0.31%)
         occurrences all number
    10
    10
    Non-cardiac chest pain
         subjects affected / exposed
    5 / 3256 (0.15%)
    3 / 3248 (0.09%)
         occurrences all number
    5
    3
    Vascular stent stenosis
         subjects affected / exposed
    9 / 3256 (0.28%)
    10 / 3248 (0.31%)
         occurrences all number
    10
    10
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 3256 (0.03%)
    5 / 3248 (0.15%)
         occurrences all number
    1
    5
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 3256 (0.15%)
    9 / 3248 (0.28%)
         occurrences all number
    5
    9
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    6 / 3256 (0.18%)
    4 / 3248 (0.12%)
         occurrences all number
    6
    5
    Cough
         subjects affected / exposed
    8 / 3256 (0.25%)
    14 / 3248 (0.43%)
         occurrences all number
    8
    14
    Dyspnoea
         subjects affected / exposed
    11 / 3256 (0.34%)
    15 / 3248 (0.46%)
         occurrences all number
    11
    15
    Dyspnoea exertional
         subjects affected / exposed
    3 / 3256 (0.09%)
    5 / 3248 (0.15%)
         occurrences all number
    3
    5
    Epistaxis
         subjects affected / exposed
    9 / 3256 (0.28%)
    3 / 3248 (0.09%)
         occurrences all number
    14
    3
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 3256 (0.00%)
    4 / 3248 (0.12%)
         occurrences all number
    0
    4
    Depression
         subjects affected / exposed
    11 / 3256 (0.34%)
    14 / 3248 (0.43%)
         occurrences all number
    12
    14
    Investigations
    Blood pressure increased
         subjects affected / exposed
    4 / 3256 (0.12%)
    6 / 3248 (0.18%)
         occurrences all number
    5
    6
    Haemoglobin decreased
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    5
    2
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    6 / 3256 (0.18%)
    6 / 3248 (0.18%)
         occurrences all number
    6
    6
    Foot fracture
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    5
    2
    Ligament sprain
         subjects affected / exposed
    0 / 3256 (0.00%)
    5 / 3248 (0.15%)
         occurrences all number
    0
    5
    Rib fracture
         subjects affected / exposed
    2 / 3256 (0.06%)
    6 / 3248 (0.18%)
         occurrences all number
    2
    6
    Muscle strain
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences all number
    4
    3
    Contusion
         subjects affected / exposed
    9 / 3256 (0.28%)
    10 / 3248 (0.31%)
         occurrences all number
    11
    11
    Limb injury
         subjects affected / exposed
    11 / 3256 (0.34%)
    11 / 3248 (0.34%)
         occurrences all number
    11
    11
    Peripheral artery restenosis
         subjects affected / exposed
    5 / 3256 (0.15%)
    6 / 3248 (0.18%)
         occurrences all number
    8
    8
    Meniscus injury
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences all number
    2
    4
    Arterial bypass occlusion
         subjects affected / exposed
    2 / 3256 (0.06%)
    5 / 3248 (0.15%)
         occurrences all number
    2
    5
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    9 / 3256 (0.28%)
    7 / 3248 (0.22%)
         occurrences all number
    10
    7
    Atrial fibrillation
         subjects affected / exposed
    31 / 3256 (0.95%)
    48 / 3248 (1.48%)
         occurrences all number
    33
    49
    Atrial flutter
         subjects affected / exposed
    7 / 3256 (0.21%)
    2 / 3248 (0.06%)
         occurrences all number
    7
    2
    Cardiac failure
         subjects affected / exposed
    3 / 3256 (0.09%)
    7 / 3248 (0.22%)
         occurrences all number
    4
    7
    Coronary artery disease
         subjects affected / exposed
    12 / 3256 (0.37%)
    9 / 3248 (0.28%)
         occurrences all number
    13
    9
    Myocardial ischaemia
         subjects affected / exposed
    6 / 3256 (0.18%)
    1 / 3248 (0.03%)
         occurrences all number
    6
    1
    Palpitations
         subjects affected / exposed
    3 / 3256 (0.09%)
    4 / 3248 (0.12%)
         occurrences all number
    3
    4
    Sinus tachycardia
         subjects affected / exposed
    4 / 3256 (0.12%)
    0 / 3248 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Carotid artery stenosis
         subjects affected / exposed
    3 / 3256 (0.09%)
    8 / 3248 (0.25%)
         occurrences all number
    3
    10
    Carpal tunnel syndrome
         subjects affected / exposed
    2 / 3256 (0.06%)
    6 / 3248 (0.18%)
         occurrences all number
    2
    6
    Diabetic neuropathy
         subjects affected / exposed
    3 / 3256 (0.09%)
    4 / 3248 (0.12%)
         occurrences all number
    3
    4
    Dizziness
         subjects affected / exposed
    23 / 3256 (0.71%)
    26 / 3248 (0.80%)
         occurrences all number
    27
    28
    Headache
         subjects affected / exposed
    18 / 3256 (0.55%)
    19 / 3248 (0.58%)
         occurrences all number
    20
    21
    Hypoaesthesia
         subjects affected / exposed
    6 / 3256 (0.18%)
    8 / 3248 (0.25%)
         occurrences all number
    7
    9
    Neuropathy peripheral
         subjects affected / exposed
    5 / 3256 (0.15%)
    1 / 3248 (0.03%)
         occurrences all number
    5
    1
    Paraesthesia
         subjects affected / exposed
    4 / 3256 (0.12%)
    9 / 3248 (0.28%)
         occurrences all number
    4
    9
    Sciatica
         subjects affected / exposed
    6 / 3256 (0.18%)
    13 / 3248 (0.40%)
         occurrences all number
    6
    14
    Syncope
         subjects affected / exposed
    3 / 3256 (0.09%)
    9 / 3248 (0.28%)
         occurrences all number
    3
    10
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    29 / 3256 (0.89%)
    23 / 3248 (0.71%)
         occurrences all number
    29
    23
    Iron deficiency anaemia
         subjects affected / exposed
    8 / 3256 (0.25%)
    3 / 3248 (0.09%)
         occurrences all number
    9
    3
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    4 / 3256 (0.12%)
    3 / 3248 (0.09%)
         occurrences all number
    5
    3
    Vertigo
         subjects affected / exposed
    7 / 3256 (0.21%)
    11 / 3248 (0.34%)
         occurrences all number
    7
    13
    Eye disorders
    Cataract
         subjects affected / exposed
    14 / 3256 (0.43%)
    9 / 3248 (0.28%)
         occurrences all number
    17
    9
    Diabetic retinopathy
         subjects affected / exposed
    4 / 3256 (0.12%)
    0 / 3248 (0.00%)
         occurrences all number
    4
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    6 / 3256 (0.18%)
    3 / 3248 (0.09%)
         occurrences all number
    7
    3
    Abdominal pain
         subjects affected / exposed
    6 / 3256 (0.18%)
    6 / 3248 (0.18%)
         occurrences all number
    6
    6
    Abdominal pain upper
         subjects affected / exposed
    19 / 3256 (0.58%)
    15 / 3248 (0.46%)
         occurrences all number
    19
    16
    Constipation
         subjects affected / exposed
    11 / 3256 (0.34%)
    13 / 3248 (0.40%)
         occurrences all number
    11
    13
    Diarrhoea
         subjects affected / exposed
    23 / 3256 (0.71%)
    22 / 3248 (0.68%)
         occurrences all number
    24
    22
    Diverticulum intestinal
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences all number
    1
    4
    Duodenal ulcer
         subjects affected / exposed
    4 / 3256 (0.12%)
    0 / 3248 (0.00%)
         occurrences all number
    4
    0
    Dyspepsia
         subjects affected / exposed
    15 / 3256 (0.46%)
    8 / 3248 (0.25%)
         occurrences all number
    16
    8
    Gastric ulcer
         subjects affected / exposed
    4 / 3256 (0.12%)
    5 / 3248 (0.15%)
         occurrences all number
    4
    5
    Gastritis
         subjects affected / exposed
    15 / 3256 (0.46%)
    8 / 3248 (0.25%)
         occurrences all number
    15
    8
    Gastritis erosive
         subjects affected / exposed
    2 / 3256 (0.06%)
    5 / 3248 (0.15%)
         occurrences all number
    2
    5
    Gastrooesophageal reflux disease
         subjects affected / exposed
    8 / 3256 (0.25%)
    8 / 3248 (0.25%)
         occurrences all number
    8
    9
    Hiatus hernia
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences all number
    4
    2
    Inguinal hernia
         subjects affected / exposed
    1 / 3256 (0.03%)
    5 / 3248 (0.15%)
         occurrences all number
    1
    5
    Nausea
         subjects affected / exposed
    14 / 3256 (0.43%)
    10 / 3248 (0.31%)
         occurrences all number
    14
    10
    Vomiting
         subjects affected / exposed
    7 / 3256 (0.21%)
    13 / 3248 (0.40%)
         occurrences all number
    7
    13
    Large intestine polyp
         subjects affected / exposed
    6 / 3256 (0.18%)
    4 / 3248 (0.12%)
         occurrences all number
    6
    4
    Hepatobiliary disorders
    Hepatic steatosis
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences all number
    4
    2
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences all number
    1
    4
    Ecchymosis
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    5
    2
    Eczema
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences all number
    2
    4
    Erythema
         subjects affected / exposed
    2 / 3256 (0.06%)
    5 / 3248 (0.15%)
         occurrences all number
    2
    5
    Pruritus
         subjects affected / exposed
    10 / 3256 (0.31%)
    7 / 3248 (0.22%)
         occurrences all number
    11
    7
    Rash
         subjects affected / exposed
    16 / 3256 (0.49%)
    18 / 3248 (0.55%)
         occurrences all number
    16
    20
    Skin ulcer
         subjects affected / exposed
    16 / 3256 (0.49%)
    18 / 3248 (0.55%)
         occurrences all number
    17
    18
    Urticaria
         subjects affected / exposed
    7 / 3256 (0.21%)
    5 / 3248 (0.15%)
         occurrences all number
    7
    5
    Diabetic foot
         subjects affected / exposed
    6 / 3256 (0.18%)
    1 / 3248 (0.03%)
         occurrences all number
    6
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    3 / 3256 (0.09%)
    4 / 3248 (0.12%)
         occurrences all number
    3
    4
    Haematuria
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences all number
    4
    2
    Renal failure
         subjects affected / exposed
    2 / 3256 (0.06%)
    5 / 3248 (0.15%)
         occurrences all number
    2
    6
    Renal impairment
         subjects affected / exposed
    4 / 3256 (0.12%)
    6 / 3248 (0.18%)
         occurrences all number
    5
    6
    Chronic kidney disease
         subjects affected / exposed
    8 / 3256 (0.25%)
    1 / 3248 (0.03%)
         occurrences all number
    8
    1
    Acute kidney injury
         subjects affected / exposed
    7 / 3256 (0.21%)
    4 / 3248 (0.12%)
         occurrences all number
    8
    4
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    18 / 3256 (0.55%)
    32 / 3248 (0.99%)
         occurrences all number
    19
    37
    Bursitis
         subjects affected / exposed
    5 / 3256 (0.15%)
    7 / 3248 (0.22%)
         occurrences all number
    6
    7
    Back pain
         subjects affected / exposed
    23 / 3256 (0.71%)
    30 / 3248 (0.92%)
         occurrences all number
    25
    33
    Joint swelling
         subjects affected / exposed
    6 / 3256 (0.18%)
    2 / 3248 (0.06%)
         occurrences all number
    6
    2
    Lumbar spinal stenosis
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    6
    4
    Muscle spasms
         subjects affected / exposed
    13 / 3256 (0.40%)
    13 / 3248 (0.40%)
         occurrences all number
    14
    16
    Muscular weakness
         subjects affected / exposed
    4 / 3256 (0.12%)
    5 / 3248 (0.15%)
         occurrences all number
    4
    6
    Musculoskeletal pain
         subjects affected / exposed
    10 / 3256 (0.31%)
    11 / 3248 (0.34%)
         occurrences all number
    10
    11
    Myalgia
         subjects affected / exposed
    6 / 3256 (0.18%)
    4 / 3248 (0.12%)
         occurrences all number
    6
    4
    Osteoarthritis
         subjects affected / exposed
    12 / 3256 (0.37%)
    14 / 3248 (0.43%)
         occurrences all number
    12
    14
    Pain in extremity
         subjects affected / exposed
    47 / 3256 (1.44%)
    52 / 3248 (1.60%)
         occurrences all number
    58
    53
    Rotator cuff syndrome
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences all number
    4
    3
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 3256 (0.06%)
    5 / 3248 (0.15%)
         occurrences all number
    2
    6
    Intervertebral disc protrusion
         subjects affected / exposed
    7 / 3256 (0.21%)
    5 / 3248 (0.15%)
         occurrences all number
    7
    5
    Spinal pain
         subjects affected / exposed
    1 / 3256 (0.03%)
    4 / 3248 (0.12%)
         occurrences all number
    1
    4
    Spinal stenosis
         subjects affected / exposed
    4 / 3256 (0.12%)
    5 / 3248 (0.15%)
         occurrences all number
    4
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    15 / 3256 (0.46%)
    17 / 3248 (0.52%)
         occurrences all number
    17
    21
    Cellulitis
         subjects affected / exposed
    10 / 3256 (0.31%)
    6 / 3248 (0.18%)
         occurrences all number
    11
    7
    Gangrene
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    5
    2
    Herpes zoster
         subjects affected / exposed
    5 / 3256 (0.15%)
    7 / 3248 (0.22%)
         occurrences all number
    5
    7
    Influenza
         subjects affected / exposed
    10 / 3256 (0.31%)
    7 / 3248 (0.22%)
         occurrences all number
    11
    8
    Localised infection
         subjects affected / exposed
    11 / 3256 (0.34%)
    7 / 3248 (0.22%)
         occurrences all number
    11
    7
    Nasopharyngitis
         subjects affected / exposed
    21 / 3256 (0.64%)
    30 / 3248 (0.92%)
         occurrences all number
    23
    32
    Osteomyelitis
         subjects affected / exposed
    4 / 3256 (0.12%)
    1 / 3248 (0.03%)
         occurrences all number
    4
    1
    Pneumonia
         subjects affected / exposed
    9 / 3256 (0.28%)
    14 / 3248 (0.43%)
         occurrences all number
    9
    14
    Postoperative wound infection
         subjects affected / exposed
    9 / 3256 (0.28%)
    9 / 3248 (0.28%)
         occurrences all number
    9
    9
    Sinusitis
         subjects affected / exposed
    6 / 3256 (0.18%)
    3 / 3248 (0.09%)
         occurrences all number
    6
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 3256 (0.12%)
    2 / 3248 (0.06%)
         occurrences all number
    4
    2
    Urinary tract infection
         subjects affected / exposed
    22 / 3256 (0.68%)
    21 / 3248 (0.65%)
         occurrences all number
    23
    27
    Wound infection
         subjects affected / exposed
    9 / 3256 (0.28%)
    4 / 3248 (0.12%)
         occurrences all number
    9
    4
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 3256 (0.06%)
    4 / 3248 (0.12%)
         occurrences all number
    2
    4
    Respiratory tract infection
         subjects affected / exposed
    5 / 3256 (0.15%)
    2 / 3248 (0.06%)
         occurrences all number
    5
    3
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    6 / 3256 (0.18%)
    12 / 3248 (0.37%)
         occurrences all number
    6
    12
    Gout
         subjects affected / exposed
    5 / 3256 (0.15%)
    11 / 3248 (0.34%)
         occurrences all number
    5
    11
    Hyperkalaemia
         subjects affected / exposed
    0 / 3256 (0.00%)
    4 / 3248 (0.12%)
         occurrences all number
    0
    4
    Vitamin D deficiency
         subjects affected / exposed
    5 / 3256 (0.15%)
    1 / 3248 (0.03%)
         occurrences all number
    5
    1
    Dyslipidaemia
         subjects affected / exposed
    1 / 3256 (0.03%)
    5 / 3248 (0.15%)
         occurrences all number
    1
    5
    Decreased appetite
         subjects affected / exposed
    6 / 3256 (0.18%)
    4 / 3248 (0.12%)
         occurrences all number
    6
    4
    Type 2 diabetes mellitus
         subjects affected / exposed
    13 / 3256 (0.40%)
    7 / 3248 (0.22%)
         occurrences all number
    13
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Feb 2016
    First global amendment including 25 changes.
    20 Mar 2017
    Second global amendment including 7 changes.

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

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