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    Clinical Trial Results:
    A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP

    Summary
    EudraCT number
    		 2010-022970-14
    Trial protocol
    		 SK   DE   HU   SE   PL   LV   LT   AT   GB   EE   GR   IS   BE   NO   CZ   IT   BG   SI  
    Global end of trial date
    14 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CACZ885M2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01327846
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma, AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharama, AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma, AG, 41 613241111, Novartis.email@novartis.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
    14 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Apr 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Core phase: The primary objective of this study was to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular events (cardiovascular death, non-fatal MI and non-fatal stroke) in a population of clinically stable patients with prior MI with elevated hsCRP receiving standard of care. Extension phase: The purpose of the Extension phase was to obtain further follow-up information on long-term safety on continued exposure to canakinumab in trial participants.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Apr 2011
    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
    Argentina: 375
    Country: Number of subjects enrolled
    Australia: 86
    Country: Number of subjects enrolled
    Austria: 58
    Country: Number of subjects enrolled
    Belgium: 94
    Country: Number of subjects enrolled
    Brazil: 719
    Country: Number of subjects enrolled
    Bulgaria: 209
    Country: Number of subjects enrolled
    Canada: 398
    Country: Number of subjects enrolled
    China: 126
    Country: Number of subjects enrolled
    Colombia: 183
    Country: Number of subjects enrolled
    Croatia: 36
    Country: Number of subjects enrolled
    Czech Republic: 382
    Country: Number of subjects enrolled
    Estonia: 70
    Country: Number of subjects enrolled
    Germany: 643
    Country: Number of subjects enrolled
    Greece: 64
    Country: Number of subjects enrolled
    Guatemala: 81
    Country: Number of subjects enrolled
    Hungary: 328
    Country: Number of subjects enrolled
    Iceland: 119
    Country: Number of subjects enrolled
    India: 592
    Country: Number of subjects enrolled
    Italy: 231
    Country: Number of subjects enrolled
    Japan: 235
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 62
    Country: Number of subjects enrolled
    Latvia: 43
    Country: Number of subjects enrolled
    Lithuania: 121
    Country: Number of subjects enrolled
    Mexico: 61
    Country: Number of subjects enrolled
    Netherlands: 623
    Country: Number of subjects enrolled
    Norway: 133
    Country: Number of subjects enrolled
    Peru: 11
    Country: Number of subjects enrolled
    Poland: 142
    Country: Number of subjects enrolled
    Romania: 293
    Country: Number of subjects enrolled
    Russian Federation: 315
    Country: Number of subjects enrolled
    Serbia: 45
    Country: Number of subjects enrolled
    Slovakia: 401
    Country: Number of subjects enrolled
    Slovenia: 78
    Country: Number of subjects enrolled
    South Africa: 63
    Country: Number of subjects enrolled
    Sweden: 202
    Country: Number of subjects enrolled
    Taiwan: 106
    Country: Number of subjects enrolled
    Turkey: 26
    Country: Number of subjects enrolled
    United Kingdom: 290
    Country: Number of subjects enrolled
    United States: 2017
    Worldwide total number of subjects
    10061
    EEA total number of subjects
    4560
    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)
    6291
    From 65 to 84 years
    3717
    85 years and over
    53

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 10066 patients enrolled in Core phase (4 randomized groups); 5 patients enrolled in safety set were not included in efficacy set. 5777 patients continued in Extension phase (539 only washout period, 5238 in treatment period(s)). The Core phase completed as planned; the Extension phase was terminated. Sub-studies terminated prior to data collection.

    Pre-assignment
    Screening details
    		 A total of 17482 patients were screened, and 10102 patients completed the screening phase. A total of 6430 patients did not complete the screening phase due to screen failure.

    Period 1
    Period 1 title
    Core Phase
    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
    		 Group I
    Arm description
    		 Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg quarterly sc (2x canakinumab 150 mg in 1mL solution)

    Arm title
    		 Group II
    Arm description
    		 Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ855
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg in 1 mL solution quarterly sc

    Arm title
    		 Group III
    Arm description
    		 Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ855
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg in 0.5 mL solution quarterly sc

    Arm title
    		 Group IV
    Arm description
    		 Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Placebo

    Investigational medicinal product name
    Canakinumab matching placebo
    Investigational medicinal product code
    Canakinumab matching placebo
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg matching placebo quarterly sc and/or 150 mg quarterly sc matching placebo

    Number of subjects in period 1
    		Group I Group II Group III Group IV
    Started
    2263
    2284
    2170
    3344
    Completed
    2235
    2252
    2144
    3311
    Not completed
    28
    32
    26
    33
         Subject decision (vital status: missing)
    1
    2
    2
    1
         Subject decision (vital stat: alive)
    23
    24
    13
    20
         Subject decision (vital stat: unkn)
    -
    -
    3
    3
         Lost to follow-up
    3
    3
    4
    5
         Subject decision (vital stat: dead)
    1
    3
    4
    4
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group I
    Arm description
    		 Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ885
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg in 1 mL solution quarterly sc

    Arm title
    		 Group II
    Arm description
    		 Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ855
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg in 1 mL solution quarterly sc

    Arm title
    		 Group III
    Arm description
    		 Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ855
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg in 1 mL solution quarterly sc

    Arm title
    		 Group IV
    Arm description
    		 Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canakinumab
    Investigational medicinal product code
    ACZ855
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 mg in 1 mL solution quarterly sc

    Number of subjects in period 2 [1]
    		Group I Group II Group III Group IV
    Started
    1267
    1287
    1279
    1944
    Stopped/discontinued study at washout
    127 [2]
    97 [3]
    137 [4]
    178 [5]
    Completed treatment period
    41 [6]
    45 [7]
    49 [8]
    60 [9]
    Details missing
    0 [10]
    1 [11]
    1 [12]
    0 [13]
    Completed
    168
    143
    187
    238
    Not completed
    1099
    1144
    1092
    1706
         Consent withdrawn by subject
    20
    13
    19
    37
         Technical Problems
    2
    4
    2
    2
         Study terminated by sponsor
    1073
    1124
    1067
    1660
         Lost to follow-up
    4
    3
    4
    7
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: This study was conducted in 2 phases: A Core phase and an extension phase.
    [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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This study was conducted in 2 phases: A Core phase and an extension phase.
    [4] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [5] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [6] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [7] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [8] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [9] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [10] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [11] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [12] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.
    [13] - 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: This study was conducted in 2 phases: A Core phase and an extension phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group II
    Reporting group description
    		 Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group III
    Reporting group description
    		 Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group IV
    Reporting group description
    		 Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group values
    		 Group I Group II Group III Group IV Total
    Number of subjects
    		 2263 2284 2170 3344 10061
    Age, Customized
    Units: Subjects
        < 65
    		 1424 1428 1350 2089 6291
        65 < 85
    		 828 838 807 1244 3717
        >85
    		 11 18 13 11 53
    Sex: Female, Male
    Units: Subjects
        Female
    		 606 575 541 865 2587
        Male
    		 1657 1709 1629 2479 7474
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 1804 1808 1772 2652 8036
        Black
    		 84 67 61 106 318
        Asian
    		 265 278 232 388 1163
        Native American
    		 47 49 41 82 219
        Pacific Islander
    		 0 0 1 1 2
        Unknown
    		 3 3 1 3 10
        Other
    		 60 79 62 112 313

    End points

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    End points reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group II
    Reporting group description
    		 Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group III
    Reporting group description
    		 Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group IV
    Reporting group description
    		 Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
    Reporting group title
    Group I
    Reporting group description
    		 Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group II
    Reporting group description
    		 Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group III
    Reporting group description
    		 Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group IV
    Reporting group description
    		 Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Primary: Analysis of Core phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and its components

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    End point title
    		 Analysis of Core phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and its components
    End point description
    Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of “Unknown” were counted as CV (cardiovascular) death.
    End point type
    Primary
    End point timeframe
    From randomization to end of treatment plus 30 days, up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    2263
    2284
    2170
    3344
    Units: Participants
        MACE
    322
    320
    313
    535
        CV death
    151
    144
    137
    235
        MI (fatal and non-fatal)
    174
    159
    169
    292
        MI (non-fatal)
    171
    158
    168
    291
        Stroke (fatal and non-fatal)
    51
    63
    58
    92
        Stroke (non-fatal)
    51
    63
    58
    91
    Statistical analysis title
    		 Primary Analysis [MACE]
    Statistical analysis description
    H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    P-value
    		 = 0.0648 [2]
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.99
    Notes
    [1] - A HR < 1 favors Canakinumab
    [2] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Primary Analysis [MACE]
    Statistical analysis description
    H21: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 150 mg dose group is greater than or equal to the hazard rate of the placebo group
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    P-value
    		 = 0.0241 [4]
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.98
    Notes
    [3] - A HR < 1 favors Canakinumab
    [4] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Primary Analysis [MACE]
    Statistical analysis description
    H31: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 50 mg dose group is greater than or equal to the hazard rate of the placebo group.
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    P-value
    		 = 0.1895 [6]
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.07
    Notes
    [5] - A HR < 1 favors Canakinumab
    [6] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Primary Analysis [CV Death]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [7]
    P-value
    		 = 0.572 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1.16
    Notes
    [7] - A HR < 1 favors Canakinumab
    [8] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [CV Death]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    P-value
    		 = 0.296 [10]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.1
    Notes
    [9] - A HR < 1 favors Canakinumab
    [10] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [CV Death]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [11]
    P-value
    		 = 0.369 [12]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.12
    Notes
    [11] - A HR < 1 favors Canakinumab
    [12] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [MI (Fatal and Non-Fatal)]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [13]
    P-value
    		 = 0.067 [14]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.01
    Notes
    [13] - A HR < 1 favors Canakinumab
    [14] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [MI (Fatal and Non-Fatal)]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [15]
    P-value
    		 = 0.006 [16]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.92
    Notes
    [15] - A HR < 1 favors Canakinumab
    [16] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [MI (Fatal and Non-Fatal)]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [17]
    P-value
    		 = 0.542 [18]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.14
    Notes
    [17] - A HR < 1 favors Canakinumab
    [18] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [MI (Non-Fatal)]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [19]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1
    Notes
    [19] - A HR < 1 favors Canakinumab
    Statistical analysis title
    		 Primary Analysis [MI (Non-Fatal)]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [20]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 0.92
    Notes
    [20] - A HR < 1 favors Canakinumab
    Statistical analysis title
    		 Primary Analysis [MI (Non-Fatal)]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [21]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.14
    Notes
    [21] - A HR < 1 favors Canakinumab
    Statistical analysis title
    		 Primary Analysis [Stroke (Fatal and Non-Fatal)]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [22]
    P-value
    		 = 0.19 [23]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.12
    Notes
    [22] - A HR < 1 favors Canakinumab
    [23] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [Stroke (Fatal and Non-Fatal)]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [24]
    P-value
    		 = 0.912 [25]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.35
    Notes
    [24] - A HR < 1 favors Canakinumab
    [25] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [Stroke (Fatal and Non-Fatal)]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [26]
    P-value
    		 = 0.871 [27]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.43
    Notes
    [26] - A HR < 1 favors Canakinumab
    [27] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Primary Analysis [Stroke (Non-Fatal)]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [28]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.13
    Notes
    [28] - A HR < 1 favors Canakinumab
    Statistical analysis title
    		 Primary Analysis [Stroke (Non-Fatal)]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [29]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.37
    Notes
    [29] - A HR < 1 favors Canakinumab
    Statistical analysis title
    		 Primary Analysis [Stroke (Non-Fatal)]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [30]
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 1.45
    Notes
    [30] - A HR < 1 favors Canakinumab

    Primary: Substudy 1 (Core phase): Change from baseline in carotid plaque burden in the bifurcation region of the index carotid artery

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    End point title
    		 Substudy 1 (Core phase): Change from baseline in carotid plaque burden in the bifurcation region of the index carotid artery [31]
    End point description
    End point type
    Primary
    End point timeframe
    24 months
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Substudy 1 was cancelled; no statistical analyses was performed.
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [32]
    0 [33]
    0 [34]
    0 [35]
    Units: carotid plaque burden
    Notes
    [32] - Analysis not performed
    [33] - Analysis not performed
    [34] - Analysis not performed
    [35] - Analysis not performed
    No statistical analyses for this end point

    Primary: Substudy 2 (Core phase): Change from baseline of the insulin secretion rate (ISR) relative to glucose 0-30 min defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 averaged across the year 3, 4, 5 visits

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    End point title
    		 Substudy 2 (Core phase): Change from baseline of the insulin secretion rate (ISR) relative to glucose 0-30 min defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 averaged across the year 3, 4, 5 visits [36]
    End point description
    End point type
    Primary
    End point timeframe
    From randomization up to approximately 6 years
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Substudy 2 was cancelled; no statistical analyses was performed.
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [37]
    0 [38]
    0 [39]
    0 [40]
    Units: change in ISR to glucose
    Notes
    [37] - Analysis not performed
    [38] - Analysis not performed
    [39] - Analysis not performed
    [40] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Patients with Core phase CEC confirmed CV death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina requiring unplanned revascularization

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    End point title
    		 Patients with Core phase CEC confirmed CV death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina requiring unplanned revascularization
    End point description
    Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee
    End point type
    Secondary
    End point timeframe
    From randomization, to end of treatment pus 30 days, up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    2263
    2284
    2170
    3344
    Units: Participants
        MACE or unstable angina
    348
    352
    344
    601
        Unstable angina
    34
    38
    38
    85
    Statistical analysis title
    		 Analysis [MACE or Unstable Angina]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [41]
    P-value
    		 = 0.0648 [42]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.94
    Notes
    [41] - A HR < 1 favors Canakinumab
    [42] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Analysis [MACE or Unstable Angina]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [43]
    P-value
    		 = 0.0241 [44]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.95
    Notes
    [43] - A HR < 1 favors Canakinumab
    [44] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Analysis [MACE or Unstable Angina]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [45]
    P-value
    		 = 0.1895 [46]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.03
    Notes
    [45] - A HR < 1 favors Canakinumab
    [46] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Analysis [Unstable Angina]
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [47]
    P-value
    		 = 0.007 [48]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 0.86
    Notes
    [47] - A HR < 1 favors Canakinumab
    [48] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Analysis [Unstable Angina]
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [49]
    P-value
    		 = 0.022 [50]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.94
    Notes
    [49] - A HR < 1 favors Canakinumab
    [50] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Analysis [Unstable Angina]
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [51]
    P-value
    		 = 0.086 [52]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.05
    Notes
    [51] - A HR < 1 favors Canakinumab
    [52] - 2-sided unadjusted p-value

    Secondary: Patients with Core phase new onset type 2 diabetes among patients with pre-diabetes at randomization

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    End point title
    		 Patients with Core phase new onset type 2 diabetes among patients with pre-diabetes at randomization
    End point description
    Time to CEC confirmed new onset of type 2 diabetes among those with pre-diabetes at randomization (i.e. excluding those that are normoglycemic at baseline)
    End point type
    Secondary
    End point timeframe
    From randomization up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    1132
    1094
    1089
    1645
    Units: Participants
    169
    171
    161
    246
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    2777
    Analysis specification
    Pre-specified
    Analysis type
    		 [53]
    P-value
    		 = 0.8456 [54]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.23
    Notes
    [53] - A HR < 1 favors Canakinumab
    [54] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    2739
    Analysis specification
    Pre-specified
    Analysis type
    		 [55]
    P-value
    		 = 0.8456 [56]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.29
    Notes
    [55] - A HR < 1 favors Canakinumab
    [56] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    2734
    Analysis specification
    Pre-specified
    Analysis type
    		 [57]
    P-value
    		 = 0.6541 [58]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.2
    Notes
    [57] - A HR < 1 favors Canakinumab
    [58] - 1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]

    Secondary: Core phase all-cause mortality, non-fatal MI, or non-fatal stroke

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    End point title
    		 Core phase all-cause mortality, non-fatal MI, or non-fatal stroke
    End point description
    Occurrence of the composite endpoint consisting of all-cause mortality, non-fatal IM, or non-fatal stroke
    End point type
    Secondary
    End point timeframe
    From randomization, to end of treatment plus 30 days, up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    2263
    2284
    2170
    3344
    Units: Participants
    403
    395
    394
    661
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.028 [59]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.99
    Notes
    [59] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.011 [60]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.96
    Notes
    [60] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.377 [61]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.07
    Notes
    [61] - 2-sided unadjusted p-value

    Secondary: Core phase all-cause mortality

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    End point title
    		 Core phase all-cause mortality
    End point description
    Number of participant deaths
    End point type
    Secondary
    End point timeframe
    From randomization, to end of treatment plus 30 days, up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    2263
    2284
    2170
    3344
    Units: Participants
    239
    238
    228
    375
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group I v Group IV
    Number of subjects included in analysis
    5607
    Analysis specification
    Pre-specified
    Analysis type
    		 [62]
    P-value
    		 = 0.406 [63]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.1
    Notes
    [62] - A HR < 1 favors Canakinumab
    [63] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group II v Group IV
    Number of subjects included in analysis
    5628
    Analysis specification
    Pre-specified
    Analysis type
    		 [64]
    P-value
    		 = 0.329 [65]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.09
    Notes
    [64] - A HR < 1 favors Canakinumab
    [65] - 2-sided unadjusted p-value
    Statistical analysis title
    		 Analysis
    Comparison groups
    Group III v Group IV
    Number of subjects included in analysis
    5514
    Analysis specification
    Pre-specified
    Analysis type
    		 [66]
    P-value
    		 = 0.597 [67]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.13
    Notes
    [66] - A HR < 1 favors Canakinumab
    [67] - 2-sided unadjusted p-value

    Secondary: Substudy 1 (Core phase): Change from baseline of the total vessel wall area at month 3 in the bifurcation region of the Index Carotid Artery

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    End point title
    		 Substudy 1 (Core phase): Change from baseline of the total vessel wall area at month 3 in the bifurcation region of the Index Carotid Artery
    End point description
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [68]
    0 [69]
    0 [70]
    0 [71]
    Units: area
    Notes
    [68] - Analysis not performed
    [69] - Analysis not performed
    [70] - Analysis not performed
    [71] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 1 (Core phase): Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24

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    End point title
    		 Substudy 1 (Core phase): Mean total vessel wall area across the left and right carotid artery at Month 3 and Month 24
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [72]
    0 [73]
    0 [74]
    0 [75]
    Units: Mean area
    Notes
    [72] - Analysis not performed
    [73] - Analysis not performed
    [74] - Analysis not performed
    [75] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 1 (Core phase): Change from baseline in corresponding total vessel wall area in the left and right carotid arteries

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    End point title
    		 Substudy 1 (Core phase): Change from baseline in corresponding total vessel wall area in the left and right carotid arteries
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [76]
    0 [77]
    0 [78]
    0 [79]
    Units: area
    Notes
    [76] - Analysis not performed
    [77] - Analysis not performed
    [78] - Analysis not performed
    [79] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 1 (Core phase): The existence of a baseline total vessel wall area by treatment interaction as well as the consistency of the treatment effect across subgroups

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    End point title
    		 Substudy 1 (Core phase): The existence of a baseline total vessel wall area by treatment interaction as well as the consistency of the treatment effect across subgroups
    End point description
    End point type
    Secondary
    End point timeframe
    24 months
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [80]
    0 [81]
    0 [82]
    0 [83]
    Units: area
    Notes
    [80] - Analysis not performed
    [81] - Analysis not performed
    [82] - Analysis not performed
    [83] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 2: (Core phase) Change from baseline in insulin sensitivity index

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    End point title
    		 Substudy 2: (Core phase) Change from baseline in insulin sensitivity index
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [84]
    0 [85]
    0 [86]
    0 [87]
    Units: Insulin sensitivity index
    Notes
    [84] - Analysis not performed
    [85] - Analysis not performed
    [86] - Analysis not performed
    [87] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 2: (Core phase) Change from baseline in OGTT stimulated area under curve (AUC) 0-120 min of glucose concentration, insulin concentration, pro-insulin concentration, and Insulin Concentration/glucose Concentration Ratio

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    End point title
    		 Substudy 2: (Core phase) Change from baseline in OGTT stimulated area under curve (AUC) 0-120 min of glucose concentration, insulin concentration, pro-insulin concentration, and Insulin Concentration/glucose Concentration Ratio
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [88]
    0 [89]
    0 [90]
    0 [91]
    Units: AUC
    Notes
    [88] - Analysis not performed
    [89] - Analysis not performed
    [90] - Analysis not performed
    [91] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 2: (Core phase) Change from Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio

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    End point title
    		 Substudy 2: (Core phase) Change from Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [92]
    0 [93]
    0 [94]
    0 [95]
    Units: Ratio
    Notes
    [92] - Analysis not performed
    [93] - Analysis not performed
    [94] - Analysis not performed
    [95] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Substudy 2: (Core phase) Change from baseline in OGTT stimulated area under the curve (AUC) 0-120 min of C-peptide Concentration

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    End point title
    		 Substudy 2: (Core phase) Change from baseline in OGTT stimulated area under the curve (AUC) 0-120 min of C-peptide Concentration
    End point description
    End point type
    Secondary
    End point timeframe
    From randomization up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    0 [96]
    0 [97]
    0 [98]
    0 [99]
    Units: AUC
    Notes
    [96] - Analysis not performed
    [97] - Analysis not performed
    [98] - Analysis not performed
    [99] - Analysis not performed
    No statistical analyses for this end point

    Secondary: Summary of Adverse Events (Core Phase)

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    End point title
    		 Summary of Adverse Events (Core Phase)
    End point description
    Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the double-blind Core phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.
    End point type
    Secondary
    End point timeframe
    From randomization, to end of treatment plus 30 days, up to approximately 6 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    2263
    2284 [100]
    2170
    3344 [101]
    Units: Participants
        Patients with at least one AE
    1987
    1970
    1872
    2915
        AEs suspected to be related to study drug
    355
    350
    267
    474
        Patients with at least one SAE
    836
    812
    741
    1204
        Discontinued due to SAEs
    135
    130
    117
    198
        Discontinued due to non-serious AEs
    40
    34
    26
    47
        AEs leading to study treatment interruption
    268
    270
    228
    399
    Notes
    [100] - The number of subjects started was 2284; number of subjects analyzed was 2285
    [101] - The number of subjects started was 3344; the number of subjects analyzed was 3348.
    No statistical analyses for this end point

    Secondary: Summary of Adverse Events (Extension Phase)

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    End point title
    		 Summary of Adverse Events (Extension Phase)
    End point description
    Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the Extension phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.
    End point type
    Secondary
    End point timeframe
    From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years
    End point values
    		 Group I Group II Group III Group IV
    Number of subjects analysed
    1267
    1287
    1279
    1944
    Units: Participants
        Patients with at least one AE
    788
    845
    793
    1250
        AEs suspected to be related to study drug
    40
    34
    43
    65
        Patients with at least one SAE
    310
    326
    322
    465
        Discontinued due to SAEs
    67
    71
    71
    98
        Discontinued due to non-serious AEs
    8
    6
    12
    8
        AEs leading to study treatment interruption
    59
    72
    62
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Core Phase: From randomization, to end of treatment plus 30 days, up to approximately 6 years. Extension Phase: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years
    Adverse event reporting additional description
    AEs/SAEs are any signs or symptoms that occur during the study treatment. During the Core phase, CV events being study endpoints were exempt from AE/SAE reporting; in contrast, during the Extension phase, all CV events were reported as AEs/SAEs. Groups I to IV show AE/SAEs during the Core phase; Group V shows AE/SAEs during the Extension phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Group I
    Reporting group description
    		 Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group II
    Reporting group description
    		 Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy. Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group III
    Reporting group description
    		 Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group IV
    Reporting group description
    		 Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Reporting group title
    Group V
    Reporting group description
    		 Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

    Serious adverse events
    		 Group I Group II Group III Group IV Group V
    Total subjects affected by serious adverse events
         subjects affected / exposed
    759 / 2263 (33.54%)
    743 / 2285 (32.52%)
    686 / 2170 (31.61%)
    1099 / 3348 (32.83%)
    1216 / 5777 (21.05%)
         number of deaths (all causes)
    239
    240
    228
    378
    211
         number of deaths resulting from adverse events
    9
    9
    11
    8
    7
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Acute leukaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    1 / 1
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    5 / 3348 (0.15%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    2 / 2
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    2 / 2
    0 / 1
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Adenoma benign
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenosquamous cell lung cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angiolipoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    14 / 2263 (0.62%)
    18 / 2285 (0.79%)
    18 / 2170 (0.83%)
    21 / 3348 (0.63%)
    30 / 5777 (0.52%)
         occurrences causally related to treatment / all
    3 / 15
    0 / 22
    0 / 19
    0 / 32
    3 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign cardiac neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of scrotum
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of skin
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign small intestinal neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign urinary tract neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bladder cancer
         subjects affected / exposed
    5 / 2263 (0.22%)
    5 / 2285 (0.22%)
    3 / 2170 (0.14%)
    5 / 3348 (0.15%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 5
    0 / 3
    3 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Bone cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    4 / 2263 (0.18%)
    0 / 2285 (0.00%)
    5 / 2170 (0.23%)
    2 / 3348 (0.06%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
    0 / 5
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Brenner tumour
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 2
    Carcinoid tumour of the gastrointestinal tract
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    3 / 2263 (0.13%)
    4 / 2285 (0.18%)
    5 / 2170 (0.23%)
    6 / 3348 (0.18%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 4
    0 / 5
    0 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    Colon neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma stage IV
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer stage III
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extranodal marginal zone B-cell lymphoma (MALT type)
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibroma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibrous histiocytoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric adenoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    5 / 2263 (0.22%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    5 / 3348 (0.15%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 1
    0 / 1
    1 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Glioma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    Hepatic cancer stage IV
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammatory pseudotumour
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    3 / 2170 (0.14%)
    7 / 3348 (0.21%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 4
    0 / 0
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lung carcinoma cell type unspecified stage III
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    4 / 2263 (0.18%)
    9 / 2285 (0.39%)
    9 / 2170 (0.41%)
    25 / 3348 (0.75%)
    14 / 5777 (0.24%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 10
    1 / 10
    3 / 25
    1 / 14
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    1 / 8
    0 / 16
    1 / 7
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoproliferative disorder
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant fibrous histiocytoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant mediastinal neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    2 / 2263 (0.09%)
    5 / 2285 (0.22%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    1 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma in situ
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of pleura
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant peritoneal neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medullary thyroid cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to adrenals
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Metastases to kidney
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Metastases to liver
         subjects affected / exposed
    2 / 2263 (0.09%)
    5 / 2285 (0.22%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 5
    0 / 1
    1 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    1 / 4
    1 / 1
    Metastases to lung
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    5 / 2170 (0.23%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 5
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 2
    0 / 1
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    Metastases to pelvis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to rectum
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to spine
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Monoclonal gammopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mucinous adenocarcinoma of appendix
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycosis fungoides
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal cavity cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine breast tumour
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma refractory
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    Oesophageal adenocarcinoma stage II
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    4 / 2170 (0.18%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 4
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oligodendroglioma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    3 / 2170 (0.14%)
    5 / 3348 (0.15%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 3
    1 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 4
    0 / 3
    1 / 3
    0 / 2
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penile cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Phaeochromocytoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleomorphic adenoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    12 / 2263 (0.53%)
    10 / 2285 (0.44%)
    10 / 2170 (0.46%)
    13 / 3348 (0.39%)
    15 / 5777 (0.26%)
         occurrences causally related to treatment / all
    2 / 12
    0 / 10
    1 / 10
    1 / 13
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    Rectal cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    Renal cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Renal cell carcinoma
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    5 / 2170 (0.23%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 5
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 1
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rosai-Dorfman syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland adenoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    5 / 3348 (0.15%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Small intestine carcinoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine carcinoma metastatic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    12 / 2263 (0.53%)
    5 / 2285 (0.22%)
    6 / 2170 (0.28%)
    10 / 3348 (0.30%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    2 / 12
    0 / 6
    0 / 6
    2 / 11
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    2 / 2263 (0.09%)
    5 / 2285 (0.22%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 5
    0 / 0
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    1 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the hypopharynx
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superficial spreading melanoma stage II
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Tonsil cancer metastatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma urethra
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Tumour perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Angiodysplasia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    8 / 2263 (0.35%)
    4 / 2285 (0.18%)
    6 / 2170 (0.28%)
    6 / 3348 (0.18%)
    12 / 5777 (0.21%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
    0 / 6
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Aortic dissection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Aortic stenosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Aortitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Arterial haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial insufficiency
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    Arteriovenous fistula
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brachiocephalic artery stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery embolism
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    2 / 2263 (0.09%)
    3 / 2285 (0.13%)
    1 / 2170 (0.05%)
    5 / 3348 (0.15%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    10 / 2263 (0.44%)
    8 / 2285 (0.35%)
    8 / 2170 (0.37%)
    15 / 3348 (0.45%)
    17 / 5777 (0.29%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
    0 / 8
    0 / 29
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Hypertensive crisis
         subjects affected / exposed
    7 / 2263 (0.31%)
    5 / 2285 (0.22%)
    2 / 2170 (0.09%)
    11 / 3348 (0.33%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 3
    0 / 13
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    8 / 2263 (0.35%)
    5 / 2285 (0.22%)
    4 / 2170 (0.18%)
    11 / 3348 (0.33%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 4
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Intermittent claudication
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic limb pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphorrhoea
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypertension
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pallor
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    3 / 2263 (0.13%)
    4 / 2285 (0.18%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    11 / 5777 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    11 / 5777 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Temporal arteritis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular insufficiency
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cardiac death
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 4
    Chest discomfort
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    3 / 2263 (0.13%)
    12 / 2285 (0.53%)
    2 / 2170 (0.09%)
    9 / 3348 (0.27%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 14
    0 / 2
    1 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    12 / 5777 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    1 / 4
    1 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    1 / 4
    1 / 12
    Drowning
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug intolerance
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial pain
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heteroplasia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hyperplasia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Implant site irritation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Influenza like illness
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injection site reaction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Local swelling
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mass
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    1 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    1 / 3
    0 / 5
    Necrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    44 / 2263 (1.94%)
    48 / 2285 (2.10%)
    39 / 2170 (1.80%)
    75 / 3348 (2.24%)
    35 / 5777 (0.61%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 53
    0 / 41
    1 / 92
    0 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Pacemaker syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudocyst
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 2263 (0.18%)
    4 / 2285 (0.18%)
    6 / 2170 (0.28%)
    5 / 3348 (0.15%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 6
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    11 / 5777 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 11
    Sudden death
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    7 / 5777 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 7
    Surgical failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    2 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Vascular stent restenosis
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Contrast media allergy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Homicide
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 2263 (0.22%)
    6 / 2285 (0.26%)
    5 / 2170 (0.23%)
    5 / 3348 (0.15%)
    8 / 5777 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 5
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysmenorrhoea
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymal cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital atrophy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Genital prolapse
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic mass
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spermatocele
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cervix stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicocele
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose veins pelvic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 4
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    10 / 2263 (0.44%)
    7 / 2285 (0.31%)
    11 / 2170 (0.51%)
    13 / 3348 (0.39%)
    21 / 5777 (0.36%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
    1 / 12
    0 / 13
    0 / 24
         deaths causally related to treatment / all
    1 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 4
    Alveolitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alveolitis allergic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    7 / 2263 (0.31%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    2 / 8
    1 / 2
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    3 / 2263 (0.13%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial obstruction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cheyne-Stokes respiration
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    28 / 2263 (1.24%)
    21 / 2285 (0.92%)
    16 / 2170 (0.74%)
    40 / 3348 (1.19%)
    33 / 5777 (0.57%)
         occurrences causally related to treatment / all
    2 / 48
    2 / 23
    1 / 21
    3 / 54
    3 / 41
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 2
    1 / 3
    Cough
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Dyspnoea
         subjects affected / exposed
    14 / 2263 (0.62%)
    8 / 2285 (0.35%)
    10 / 2170 (0.46%)
    23 / 3348 (0.69%)
    19 / 5777 (0.33%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 9
    0 / 10
    0 / 25
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Dyspnoea exertional
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    6 / 3348 (0.18%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    4 / 3348 (0.12%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 7
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypopnoea
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic interstitial pneumonia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pneumonia syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    2 / 2
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung hernia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal obstruction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal turbinate hypertrophy
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural adhesion
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    8 / 2263 (0.35%)
    5 / 2285 (0.22%)
    4 / 2170 (0.18%)
    6 / 3348 (0.18%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 5
    0 / 4
    2 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    5 / 2263 (0.22%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    4 / 3348 (0.12%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    18 / 5777 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 2
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    Pulmonary fibrosis
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    4 / 3348 (0.12%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    Pulmonary haematoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    2 / 2263 (0.09%)
    3 / 2285 (0.13%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pulmonary microemboli
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    4 / 2263 (0.18%)
    4 / 2285 (0.18%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory alkalosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Respiratory failure
         subjects affected / exposed
    12 / 2263 (0.53%)
    11 / 2285 (0.48%)
    9 / 2170 (0.41%)
    12 / 3348 (0.36%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 11
    0 / 9
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    0 / 3
    0 / 4
    0 / 1
    Respiratory tract inflammation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Respiratory tract irritation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinitis allergic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus congestion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus polyp
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    5 / 3348 (0.15%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vocal cord leukoplakia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute stress disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adjustment disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholic psychosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burnout syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    7 / 2263 (0.31%)
    4 / 2285 (0.18%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Dissociative amnesia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug use disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised anxiety disorder
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination, visual
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head banging
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Homicidal ideation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Major depression
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    4 / 2263 (0.18%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    6 / 3348 (0.18%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
    0 / 2
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Personality change
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder due to a general medical condition
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somnambulism
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Device battery issue
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device end of service
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device inappropriate shock delivery
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device issue
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device lead damage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device lead issue
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device loosening
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device signal detection issue
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lead dislodgement
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Alcoholic liver disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    4 / 2263 (0.18%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary cirrhosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary fistula
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    4 / 2170 (0.18%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    1 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    11 / 2263 (0.49%)
    4 / 2285 (0.18%)
    8 / 2170 (0.37%)
    9 / 3348 (0.27%)
    7 / 5777 (0.12%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 4
    0 / 8
    1 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    5 / 2263 (0.22%)
    7 / 2285 (0.31%)
    4 / 2170 (0.18%)
    7 / 3348 (0.21%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 7
    0 / 6
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    8 / 2263 (0.35%)
    8 / 2285 (0.35%)
    8 / 2170 (0.37%)
    18 / 3348 (0.54%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
    0 / 9
    0 / 20
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder polyp
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic hepatic cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic congestion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hepatic function abnormal
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic steatosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic vein thrombosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatomegaly
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatorenal failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hepatosplenomegaly
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocholecystis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-alcoholic fatty liver
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Steatohepatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Body mass index decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central venous pressure increased
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest X-ray abnormal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Clostridium test positive
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Human metapneumovirus test positive
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Imaging procedure abnormal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    International normalised ratio decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Quality of life decreased
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scan myocardial perfusion abnormal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin T increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volume blood decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    5 / 2263 (0.22%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 3
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asbestosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac function disturbance postoperative
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central cord syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Closed globe injury
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    5 / 3348 (0.15%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dural tear
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epicondylitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 2263 (0.13%)
    5 / 2285 (0.22%)
    2 / 2170 (0.09%)
    5 / 3348 (0.15%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    2 / 2170 (0.09%)
    5 / 3348 (0.15%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture displacement
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma necrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    6 / 3348 (0.18%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Incision site pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia, obstructive
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    Intentional overdose
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional product misuse
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    4 / 2263 (0.18%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    5 / 2170 (0.23%)
    8 / 3348 (0.24%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 5
    0 / 9
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle contusion
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal foreign body
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirenal haematoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural discharge
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural fever
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative hernia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiation mucositis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    4 / 2263 (0.18%)
    3 / 2285 (0.13%)
    3 / 2170 (0.14%)
    7 / 3348 (0.21%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Road traffic accident
         subjects affected / exposed
    4 / 2263 (0.18%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 2
    0 / 2
    Scapula fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scratch
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skeletal injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    5 / 3348 (0.15%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    2 / 2263 (0.09%)
    4 / 2285 (0.18%)
    4 / 2170 (0.18%)
    5 / 3348 (0.15%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 4
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Tendon injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic amputation
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic arthritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm ruptured
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Branchial cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular arteriovenous malformation
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic arteriovenous malformation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hereditary haemochromatosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nonketotic hyperglycinaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyloric stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheo-oesophageal fistula
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    6 / 2263 (0.27%)
    1 / 2285 (0.04%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    14 / 5777 (0.24%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 4
    1 / 4
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    Acute left ventricular failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    7 / 3348 (0.21%)
    71 / 5777 (1.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 7
    0 / 83
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 2
    Adams-Stokes syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    42 / 2263 (1.86%)
    41 / 2285 (1.79%)
    37 / 2170 (1.71%)
    76 / 3348 (2.27%)
    66 / 5777 (1.14%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 52
    0 / 43
    3 / 84
    0 / 72
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    39 / 2263 (1.72%)
    34 / 2285 (1.49%)
    37 / 2170 (1.71%)
    63 / 3348 (1.88%)
    56 / 5777 (0.97%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 45
    0 / 37
    1 / 72
    0 / 57
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    4 / 2263 (0.18%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    3 / 2263 (0.13%)
    6 / 2285 (0.26%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    49 / 5777 (0.85%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 4
    0 / 5
    1 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 2
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    10 / 3348 (0.30%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
    0 / 3
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    2 / 2263 (0.09%)
    7 / 2285 (0.31%)
    7 / 2170 (0.32%)
    15 / 3348 (0.45%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 7
    0 / 16
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 4
    0 / 6
    0 / 6
    Cardiac discomfort
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    5 / 2263 (0.22%)
    4 / 2285 (0.18%)
    7 / 2170 (0.32%)
    4 / 3348 (0.12%)
    43 / 5777 (0.74%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 8
    0 / 4
    1 / 54
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 9
    Cardiac failure acute
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    16 / 5777 (0.28%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 17
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Cardiac failure chronic
         subjects affected / exposed
    5 / 2263 (0.22%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    15 / 5777 (0.26%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
    0 / 2
    1 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Cardiac failure congestive
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    30 / 5777 (0.52%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 0
    0 / 37
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    Cardiac fibrillation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac pseudoaneurysm
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    1 / 3348 (0.03%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 1
    0 / 5
    Cardiogenic shock
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    3 / 2170 (0.14%)
    7 / 3348 (0.21%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 4
    0 / 8
    1 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 4
    1 / 5
    Cardiomegaly
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Conduction disorder
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    9 / 2263 (0.40%)
    10 / 2285 (0.44%)
    5 / 2170 (0.23%)
    20 / 3348 (0.60%)
    27 / 5777 (0.47%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 13
    0 / 8
    0 / 29
    0 / 28
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Coronary artery stenosis
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    14 / 5777 (0.24%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 2
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    3 / 2263 (0.13%)
    5 / 2285 (0.22%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 2
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    Left ventricular dysfunction
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microvascular coronary artery disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 2263 (0.22%)
    3 / 2285 (0.13%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 3
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    5 / 2170 (0.23%)
    2 / 3348 (0.06%)
    42 / 5777 (0.73%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
    0 / 2
    1 / 42
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 5
    0 / 2
    0 / 10
    Myocardial ischaemia
         subjects affected / exposed
    6 / 2263 (0.27%)
    3 / 2285 (0.13%)
    5 / 2170 (0.23%)
    6 / 3348 (0.18%)
    10 / 5777 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 5
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    Nodal arrhythmia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular dysfunction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Silent myocardial infarction
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    3 / 2263 (0.13%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    5 / 2170 (0.23%)
    4 / 3348 (0.12%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    4 / 2263 (0.18%)
    9 / 2285 (0.39%)
    3 / 2170 (0.14%)
    7 / 3348 (0.21%)
    7 / 5777 (0.12%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 9
    0 / 3
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 3
    Ventricular tachyarrhythmia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    10 / 2263 (0.44%)
    5 / 2285 (0.22%)
    9 / 2170 (0.41%)
    16 / 3348 (0.48%)
    18 / 5777 (0.31%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
    0 / 9
    0 / 26
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Apraxia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    3 / 2263 (0.13%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    8 / 5777 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 1
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Cerebrovascular accident
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    22 / 5777 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 4
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dementia with Lewy bodies
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic coma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplegia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    6 / 2263 (0.27%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    7 / 3348 (0.21%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 3
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysaesthesia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dystonia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Epilepsy
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Facial paralysis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Focal dyscognitive seizures
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Headache
         subjects affected / exposed
    4 / 2263 (0.18%)
    3 / 2285 (0.13%)
    3 / 2170 (0.14%)
    4 / 3348 (0.12%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 3
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersomnia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic encephalopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    IIIrd nerve paresis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    16 / 5777 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Lacunar infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbosacral radiculopathy
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental impairment
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mixed dementia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic neuritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic intolerance
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Paresis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral nerve lesion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post stroke seizure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    5 / 2170 (0.23%)
    4 / 3348 (0.12%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 6
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stupor
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    15 / 2263 (0.66%)
    17 / 2285 (0.74%)
    16 / 2170 (0.74%)
    25 / 3348 (0.75%)
    16 / 5777 (0.28%)
         occurrences causally related to treatment / all
    0 / 16
    1 / 19
    2 / 17
    0 / 27
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tension headache
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonic convulsion
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    15 / 5777 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper motor neurone lesion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Abnormal clotting factor
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    15 / 2263 (0.66%)
    10 / 2285 (0.44%)
    4 / 2170 (0.18%)
    14 / 3348 (0.42%)
    10 / 5777 (0.17%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 11
    0 / 5
    1 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
    0 / 1
    Bone marrow oedema
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    5 / 2170 (0.23%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hilar lymphadenopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Histiocytosis haematophagic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Monoclonal B-cell lymphocytosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normocytic anaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    5 / 2263 (0.22%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
    1 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Thrombocytopenic purpura
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otosclerosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presbyacusis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 2263 (0.13%)
    5 / 2285 (0.22%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness transient
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    4 / 2263 (0.18%)
    8 / 2285 (0.35%)
    5 / 2170 (0.23%)
    12 / 3348 (0.36%)
    8 / 5777 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
    0 / 8
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract cortical
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract diabetic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corneal degeneration
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corneal infiltrates
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ocular ischaemic syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papilloedema
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal artery thrombosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Abdominal hernia
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    7 / 2263 (0.31%)
    4 / 2285 (0.18%)
    10 / 2170 (0.46%)
    10 / 3348 (0.30%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    1 / 10
    1 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    6 / 2263 (0.27%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 3
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal skin tags
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal ulcer haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anorectal disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal mucocoele
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendix disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Change of bowel habit
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    3 / 2263 (0.13%)
    3 / 2285 (0.13%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    1 / 2
    0 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Colitis microscopic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic fistula
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dental caries
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic gastroenteropathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 2263 (0.13%)
    5 / 2285 (0.22%)
    4 / 2170 (0.18%)
    2 / 3348 (0.06%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    1 / 5
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dieulafoy's vascular malformation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epigastric discomfort
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erosive duodenitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallstone ileus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    7 / 2263 (0.31%)
    6 / 2285 (0.26%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric volvulus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    4 / 2263 (0.18%)
    1 / 2285 (0.04%)
    4 / 2170 (0.18%)
    6 / 3348 (0.18%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal erosion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    13 / 2263 (0.57%)
    16 / 2285 (0.70%)
    14 / 2170 (0.65%)
    13 / 3348 (0.39%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 23
    0 / 18
    0 / 14
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    0 / 0
    0 / 1
    Gastrointestinal necrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 2263 (0.04%)
    5 / 2285 (0.22%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 2263 (0.04%)
    3 / 2285 (0.13%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic necrotic pancreatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 2263 (0.09%)
    3 / 2285 (0.13%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileal ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    8 / 2263 (0.35%)
    5 / 2285 (0.22%)
    7 / 2170 (0.32%)
    7 / 3348 (0.21%)
    8 / 5777 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 8
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Intestinal mass
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Intestinal ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic enteritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    3 / 2263 (0.13%)
    4 / 2285 (0.18%)
    2 / 2170 (0.09%)
    12 / 3348 (0.36%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
    1 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Mesenteric vascular insufficiency
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Mouth cyst
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Narcotic bowel syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    4 / 2263 (0.18%)
    3 / 2285 (0.13%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal rupture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Oesophagitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic duct dilatation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    6 / 2263 (0.27%)
    6 / 2285 (0.26%)
    3 / 2170 (0.14%)
    11 / 3348 (0.33%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 3
    1 / 13
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Pancreatitis acute
         subjects affected / exposed
    3 / 2263 (0.13%)
    6 / 2285 (0.26%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 2
    0 / 3
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis necrotising
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumatosis intestinalis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctalgia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ranula
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    6 / 2285 (0.26%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal lesion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal perforation
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Small intestinal perforation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestine ulcer
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 2263 (0.13%)
    8 / 2285 (0.35%)
    8 / 2170 (0.37%)
    8 / 3348 (0.24%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    2 / 8
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 2263 (0.22%)
    4 / 2285 (0.18%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Actinic keratosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blister
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brow ptosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 2263 (0.04%)
    6 / 2285 (0.26%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkeratosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity vasculitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurodermatitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prurigo
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pruritus allergic
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinophyma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    5 / 2285 (0.22%)
    5 / 2170 (0.23%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 6
    0 / 6
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous emphysema
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    20 / 2263 (0.88%)
    30 / 2285 (1.31%)
    16 / 2170 (0.74%)
    27 / 3348 (0.81%)
    22 / 5777 (0.38%)
         occurrences causally related to treatment / all
    1 / 21
    0 / 31
    0 / 20
    3 / 29
    1 / 25
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 2
    1 / 1
    0 / 0
    Acute prerenal failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anuria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    4 / 2263 (0.18%)
    5 / 2285 (0.22%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 5
    0 / 4
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    Diabetic nephropathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis membranous
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    5 / 2263 (0.22%)
    6 / 2285 (0.26%)
    3 / 2170 (0.14%)
    7 / 3348 (0.21%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 3
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 2263 (0.09%)
    3 / 2285 (0.13%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive nephropathy
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower urinary tract symptoms
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    4 / 2170 (0.18%)
    7 / 3348 (0.21%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pollakiuria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyuria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery thrombosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    7 / 2263 (0.31%)
    10 / 2285 (0.44%)
    11 / 2170 (0.51%)
    13 / 3348 (0.39%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
    0 / 11
    0 / 14
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    0 / 4
    0 / 0
    Renal haematoma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    3 / 2170 (0.14%)
    1 / 3348 (0.03%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    7 / 3348 (0.21%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 2
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    4 / 2263 (0.18%)
    4 / 2285 (0.18%)
    3 / 2170 (0.14%)
    4 / 3348 (0.12%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 3
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vesicocutaneous fistula
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypopituitarism
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Primary hyperaldosteronism
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic goitre
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 2263 (0.09%)
    5 / 2285 (0.22%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 2
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    4 / 2263 (0.18%)
    8 / 2285 (0.35%)
    5 / 2170 (0.23%)
    7 / 3348 (0.21%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 5
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondromalacia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dactylitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fasciitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Finger deformity
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fracture malunion
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gouty tophus
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immunoglobulin G4 related disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc calcification
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc compression
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc displacement
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    4 / 2263 (0.18%)
    2 / 2285 (0.09%)
    6 / 2170 (0.28%)
    10 / 3348 (0.30%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 6
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Jaw cyst
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    4 / 2285 (0.18%)
    1 / 2170 (0.05%)
    5 / 3348 (0.15%)
    5 / 5777 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metatarsalgia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle atrophy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle swelling
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    3 / 2263 (0.13%)
    3 / 2285 (0.13%)
    5 / 2170 (0.23%)
    5 / 3348 (0.15%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 5
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myofascial pain syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathic arthropathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    19 / 2263 (0.84%)
    21 / 2285 (0.92%)
    18 / 2170 (0.83%)
    51 / 3348 (1.52%)
    26 / 5777 (0.45%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 24
    0 / 20
    0 / 53
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    5 / 2263 (0.22%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in jaw
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    5 / 3348 (0.15%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shoulder deformity
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue mass
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    6 / 2263 (0.27%)
    2 / 2285 (0.09%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal deformity
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    5 / 3348 (0.15%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebral wedging
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    4 / 2263 (0.18%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 1
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    Abscess oral
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess soft tissue
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute hepatitis B
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 2263 (0.13%)
    4 / 2285 (0.18%)
    6 / 2170 (0.28%)
    4 / 3348 (0.12%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
    1 / 6
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Bacteroides infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bartholin's abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Beta haemolytic streptococcal infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    10 / 2263 (0.44%)
    9 / 2285 (0.39%)
    6 / 2170 (0.28%)
    14 / 3348 (0.42%)
    10 / 5777 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 9
    1 / 8
    1 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Bronchitis bacterial
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bursitis infective
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective staphylococcal
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Candida infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Carbuncle
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    29 / 2263 (1.28%)
    32 / 2285 (1.40%)
    19 / 2170 (0.88%)
    27 / 3348 (0.81%)
    22 / 5777 (0.38%)
         occurrences causally related to treatment / all
    6 / 35
    9 / 37
    2 / 21
    4 / 29
    2 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    Cellulitis gangrenous
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis of male external genital organ
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chikungunya virus infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chorioretinitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic tonsillitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    4 / 2170 (0.18%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    1 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Creutzfeldt-Jakob disease
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cystitis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    4 / 3348 (0.12%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Device related sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    8 / 2263 (0.35%)
    9 / 2285 (0.39%)
    8 / 2170 (0.37%)
    13 / 3348 (0.39%)
    6 / 5777 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 9
    4 / 8
    3 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    2 / 3348 (0.06%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    6 / 2263 (0.27%)
    12 / 2285 (0.53%)
    6 / 2170 (0.28%)
    9 / 3348 (0.27%)
    13 / 5777 (0.23%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 13
    1 / 6
    2 / 9
    2 / 13
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    External ear cellulitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Folliculitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungal skin infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    5 / 2170 (0.23%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 7
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastritis viral
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 2263 (0.27%)
    5 / 2285 (0.22%)
    6 / 2170 (0.28%)
    8 / 3348 (0.24%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 6
    0 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemophilus sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic pneumonia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic amoebiasis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis viral
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes ophthalmic
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    4 / 3348 (0.12%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Human ehrlichiosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypopyon
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Implant site abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Incision site cellulitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected bite
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    5 / 2263 (0.22%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 0
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective spondylitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    4 / 2263 (0.18%)
    6 / 2285 (0.26%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    9 / 5777 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 2
    0 / 3
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    Intervertebral discitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leptospirosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Localised infection
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    3 / 2170 (0.14%)
    5 / 3348 (0.15%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
    0 / 3
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    4 / 2170 (0.18%)
    4 / 3348 (0.12%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    1 / 4
    0 / 4
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    3 / 2170 (0.14%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Meningococcal sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycobacterial infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    4 / 2263 (0.18%)
    3 / 2285 (0.13%)
    3 / 2170 (0.14%)
    4 / 3348 (0.12%)
    10 / 5777 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
    0 / 3
    1 / 4
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis bacterial
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis blastomyces
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pancreatic abscess
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parametritis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perichondritis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    2 / 3348 (0.06%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    2 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pharyngeal abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    67 / 2263 (2.96%)
    60 / 2285 (2.63%)
    53 / 2170 (2.44%)
    83 / 3348 (2.48%)
    70 / 5777 (1.21%)
         occurrences causally related to treatment / all
    13 / 72
    15 / 69
    9 / 58
    17 / 95
    10 / 73
         deaths causally related to treatment / all
    1 / 13
    2 / 12
    2 / 9
    1 / 5
    1 / 5
    Pneumonia bacterial
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia escherichia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    Pneumonia legionella
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia necrotising
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    2 / 2263 (0.09%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Proctitis infectious
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Propionibacterium infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Pseudomonas bronchitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 2
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 2
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    5 / 3348 (0.15%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
    1 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 2263 (0.04%)
    5 / 2285 (0.22%)
    1 / 2170 (0.05%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Pyoderma
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyuria
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    2 / 2263 (0.09%)
    7 / 2285 (0.31%)
    0 / 2170 (0.00%)
    7 / 3348 (0.21%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 7
    0 / 0
    3 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rubella
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrub typhus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    19 / 2263 (0.84%)
    25 / 2285 (1.09%)
    15 / 2170 (0.69%)
    19 / 3348 (0.57%)
    22 / 5777 (0.38%)
         occurrences causally related to treatment / all
    5 / 19
    9 / 25
    3 / 15
    5 / 21
    3 / 22
         deaths causally related to treatment / all
    3 / 7
    2 / 12
    0 / 6
    4 / 8
    0 / 5
    Sepsis syndrome
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic embolus
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic necrosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    6 / 2263 (0.27%)
    8 / 2285 (0.35%)
    6 / 2170 (0.28%)
    11 / 3348 (0.33%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
    2 / 6
    1 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    1 / 5
    0 / 7
    0 / 2
    Sialoadenitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    3 / 2263 (0.13%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis fungal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    3 / 5777 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    0 / 0
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal mediastinitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    2 / 3348 (0.06%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    4 / 2263 (0.18%)
    3 / 2285 (0.13%)
    2 / 2170 (0.09%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 3
    0 / 2
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural empyema
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Testicular abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tetanus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Tuberculosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    13 / 2263 (0.57%)
    11 / 2285 (0.48%)
    10 / 2170 (0.46%)
    21 / 3348 (0.63%)
    19 / 5777 (0.33%)
         occurrences causally related to treatment / all
    3 / 13
    5 / 12
    0 / 10
    3 / 24
    4 / 20
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    1 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    3 / 2263 (0.13%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    4 / 2263 (0.18%)
    4 / 2285 (0.18%)
    5 / 2170 (0.23%)
    3 / 3348 (0.09%)
    7 / 5777 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    1 / 5
    1 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    Vestibular neuronitis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral cardiomyopathy
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulval abscess
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 2263 (0.00%)
    3 / 2285 (0.13%)
    4 / 2170 (0.18%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    1 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    5 / 2263 (0.22%)
    6 / 2285 (0.26%)
    6 / 2170 (0.28%)
    6 / 3348 (0.18%)
    8 / 5777 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
    0 / 6
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    3 / 2263 (0.13%)
    10 / 2285 (0.44%)
    1 / 2170 (0.05%)
    11 / 3348 (0.33%)
    8 / 5777 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
    0 / 1
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 2263 (0.09%)
    1 / 2285 (0.04%)
    7 / 2170 (0.32%)
    3 / 3348 (0.09%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 8
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes with hyperosmolarity
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic complication
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    2 / 5777 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    3 / 3348 (0.09%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperammonaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperchloraemia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 2263 (0.13%)
    4 / 2285 (0.18%)
    3 / 2170 (0.14%)
    6 / 3348 (0.18%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 2263 (0.13%)
    4 / 2285 (0.18%)
    3 / 2170 (0.14%)
    3 / 3348 (0.09%)
    7 / 5777 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hypermagnesaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    4 / 2263 (0.18%)
    4 / 2285 (0.18%)
    3 / 2170 (0.14%)
    9 / 3348 (0.27%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 4
    0 / 3
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    3 / 2170 (0.14%)
    9 / 3348 (0.27%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 11
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    2 / 2263 (0.09%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 2263 (0.00%)
    2 / 2285 (0.09%)
    4 / 2170 (0.18%)
    2 / 3348 (0.06%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insulin resistant diabetes
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insulin-requiring type 2 diabetes mellitus
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 2263 (0.00%)
    0 / 2285 (0.00%)
    1 / 2170 (0.05%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    0 / 2285 (0.00%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 2263 (0.04%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    1 / 5777 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 2263 (0.04%)
    2 / 2285 (0.09%)
    2 / 2170 (0.09%)
    1 / 3348 (0.03%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    Obesity
         subjects affected / exposed
    5 / 2263 (0.22%)
    1 / 2285 (0.04%)
    1 / 2170 (0.05%)
    2 / 3348 (0.06%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 2263 (0.00%)
    1 / 2285 (0.04%)
    0 / 2170 (0.00%)
    0 / 3348 (0.00%)
    0 / 5777 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    3 / 2263 (0.13%)
    2 / 2285 (0.09%)
    1 / 2170 (0.05%)
    1 / 3348 (0.03%)
    4 / 5777 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group I Group II Group III Group IV Group V
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1271 / 2263 (56.16%)
    1324 / 2285 (57.94%)
    1199 / 2170 (55.25%)
    1905 / 3348 (56.90%)
    1497 / 5777 (25.91%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    198 / 2263 (8.75%)
    216 / 2285 (9.45%)
    208 / 2170 (9.59%)
    309 / 3348 (9.23%)
    241 / 5777 (4.17%)
         occurrences all number
    242
    258
    249
    386
    261
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    142 / 2263 (6.27%)
    164 / 2285 (7.18%)
    129 / 2170 (5.94%)
    228 / 3348 (6.81%)
    115 / 5777 (1.99%)
         occurrences all number
    176
    202
    166
    284
    126
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    114 / 2263 (5.04%)
    126 / 2285 (5.51%)
    132 / 2170 (6.08%)
    189 / 3348 (5.65%)
    107 / 5777 (1.85%)
         occurrences all number
    132
    148
    157
    223
    122
    Headache
         subjects affected / exposed
    133 / 2263 (5.88%)
    111 / 2285 (4.86%)
    120 / 2170 (5.53%)
    178 / 3348 (5.32%)
    72 / 5777 (1.25%)
         occurrences all number
    163
    139
    183
    245
    85
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    113 / 2263 (4.99%)
    99 / 2285 (4.33%)
    84 / 2170 (3.87%)
    169 / 3348 (5.05%)
    72 / 5777 (1.25%)
         occurrences all number
    126
    116
    91
    191
    76
    Non-cardiac chest pain
         subjects affected / exposed
    142 / 2263 (6.27%)
    143 / 2285 (6.26%)
    111 / 2170 (5.12%)
    228 / 3348 (6.81%)
    68 / 5777 (1.18%)
         occurrences all number
    172
    169
    137
    284
    71
    Oedema peripheral
         subjects affected / exposed
    136 / 2263 (6.01%)
    142 / 2285 (6.21%)
    134 / 2170 (6.18%)
    173 / 3348 (5.17%)
    110 / 5777 (1.90%)
         occurrences all number
    156
    161
    153
    196
    117
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    138 / 2263 (6.10%)
    146 / 2285 (6.39%)
    137 / 2170 (6.31%)
    216 / 3348 (6.45%)
    110 / 5777 (1.90%)
         occurrences all number
    178
    194
    201
    277
    127
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    151 / 2263 (6.67%)
    152 / 2285 (6.65%)
    121 / 2170 (5.58%)
    233 / 3348 (6.96%)
    103 / 5777 (1.78%)
         occurrences all number
    187
    171
    135
    288
    115
    Dyspnoea
         subjects affected / exposed
    126 / 2263 (5.57%)
    123 / 2285 (5.38%)
    110 / 2170 (5.07%)
    193 / 3348 (5.76%)
    112 / 5777 (1.94%)
         occurrences all number
    143
    140
    133
    219
    121
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    165 / 2263 (7.29%)
    181 / 2285 (7.92%)
    144 / 2170 (6.64%)
    252 / 3348 (7.53%)
    184 / 5777 (3.19%)
         occurrences all number
    199
    226
    169
    297
    200
    Back pain
         subjects affected / exposed
    169 / 2263 (7.47%)
    177 / 2285 (7.75%)
    157 / 2170 (7.24%)
    277 / 3348 (8.27%)
    163 / 5777 (2.82%)
         occurrences all number
    197
    200
    171
    327
    169
    Pain in extremity
         subjects affected / exposed
    145 / 2263 (6.41%)
    145 / 2285 (6.35%)
    98 / 2170 (4.52%)
    204 / 3348 (6.09%)
    128 / 5777 (2.22%)
         occurrences all number
    171
    166
    114
    242
    139
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    131 / 2263 (5.79%)
    162 / 2285 (7.09%)
    114 / 2170 (5.25%)
    234 / 3348 (6.99%)
    160 / 5777 (2.77%)
         occurrences all number
    164
    204
    151
    322
    183
    Influenza
         subjects affected / exposed
    141 / 2263 (6.23%)
    145 / 2285 (6.35%)
    118 / 2170 (5.44%)
    194 / 3348 (5.79%)
    154 / 5777 (2.67%)
         occurrences all number
    168
    167
    147
    248
    163
    Upper respiratory tract infection
         subjects affected / exposed
    153 / 2263 (6.76%)
    156 / 2285 (6.83%)
    134 / 2170 (6.18%)
    252 / 3348 (7.53%)
    125 / 5777 (2.16%)
         occurrences all number
    214
    214
    189
    343
    158
    Urinary tract infection
         subjects affected / exposed
    126 / 2263 (5.57%)
    129 / 2285 (5.65%)
    93 / 2170 (4.29%)
    175 / 3348 (5.23%)
    123 / 5777 (2.13%)
         occurrences all number
    175
    194
    130
    247
    145
    Viral upper respiratory tract infection
         subjects affected / exposed
    264 / 2263 (11.67%)
    297 / 2285 (13.00%)
    263 / 2170 (12.12%)
    388 / 3348 (11.59%)
    16 / 5777 (0.28%)
         occurrences all number
    428
    477
    439
    641
    16

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Sep 2016
    Amendment #9 to add the Extension Phase

    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.
    Comparison across groups is no longer feasible in the Extension phase because all patients received canakinumab 150 mg. Beyond the primary endpoint, all p-values for the canakinumab 50 mg and 300 mg groups are to be considered nominal only.
    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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