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    Clinical Trial Results:
    A Phase 3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2006-003399-37
    Trial protocol
    DE   HU   AT   BE   FR   LT   LV   NL   DK   SE   BG   SK   CZ  
    Global end of trial date
    12 Feb 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jun 2016
    First version publication date
    04 Jun 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C0524T18
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00488631
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Janssen Research and Development, Clinical Registry Group-JB BV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research and Development, Clinical Registry Group-JB BV, ClinicalTrialsEU@its.jnj.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
    12 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of maintenance regimens of CNTO 148 (golimumab) in maintaining clinical response through Week 54.
    Protection of trial subjects
    The safety assessments included vital signs, physical examinations (including skin examinations), clinical laboratory tests, adverse events (AEs), antinuclear antibodies (ANAs) and anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies, tuberculosis (TB) evaluations, and pregnancy testing.
    Background therapy
    Subjects could have been receiving concomitant treatment with 5-ASAs, corticosteroids, and /or immunomodulators {(ie. 6-MP, azathioprine (AZA), or methotrexate (MTX)} on entry into the maintenance study.
    Evidence for comparator
    No
    Actual start date of recruitment
    28 Sep 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety, Efficacy
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Slovakia: 52
    Country: Number of subjects enrolled
    South Africa: 9
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    Ukraine: 34
    Country: Number of subjects enrolled
    United States: 268
    Country: Number of subjects enrolled
    Australia: 64
    Country: Number of subjects enrolled
    Austria: 25
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Bulgaria: 57
    Country: Number of subjects enrolled
    Canada: 55
    Country: Number of subjects enrolled
    Czech Republic: 10
    Country: Number of subjects enrolled
    Denmark: 20
    Country: Number of subjects enrolled
    France: 24
    Country: Number of subjects enrolled
    Germany: 59
    Country: Number of subjects enrolled
    Hungary: 106
    Country: Number of subjects enrolled
    India: 80
    Country: Number of subjects enrolled
    Israel: 39
    Country: Number of subjects enrolled
    Japan: 62
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    New Zealand: 22
    Country: Number of subjects enrolled
    Poland: 142
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    Serbia: 35
    Worldwide total number of subjects
    1228
    EEA total number of subjects
    540
    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)
    1178
    From 65 to 84 years
    50
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted from 28 September 2007 to 12 February 2015.

    Pre-assignment
    Screening details
    A total of 1,228 subjects were enrolled in study among these subjects 464 subjects received randomized treatment and 764 received nonrandomized treatment

    Period 1
    Period 1 title
    Double blind period (Week 0-54)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
    Arm description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study. Subjects with loss of clinical response had their dose increased to golimumab 100 milligram (mg) subcutaneous injection administered every 4 weeks through Week 52.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study.

    Investigational medicinal product name
    Golimumab 100 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 after dose adjustment following loss of clinical response.

    Arm title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
    Arm description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study. Subjects with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects receive golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52.

    Investigational medicinal product name
    Golimumab 100 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 after dose adjustment following loss of clinical response.

    Arm title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
    Arm description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18. Subjects with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52 (prior to protocol amendment 3).
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 100 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

    Investigational medicinal product name
    Golimumab 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 200 mg every 4 weeks through Week 52 after dose adjustment following loss of clinical response. Following amendment 3, Subjects remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.

    Arm title
    Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance
    Arm description
    Subjects in clinical response to placebo at Week 6 of induction study (C0524T16 or C0524T17) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study. These subjects were not randomized. Subjects with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52.

    Investigational medicinal product name
    Golimumab 100 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 after dose increase following loss of clinical response.

    Arm title
    PBO-I-nonRsp-Golimumab 100 mg Maintenance
    Arm description
    Subjects not in clinical response to placebo at Week 6 induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52; not randomized.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 100 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

    Arm title
    GLM-I-nonRsp-Golimumab 100 mg Maintenance
    Arm description
    Subjects not in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52; not randomized.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 100 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

    Number of subjects in period 1
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance PBO-I-nonRsp-Golimumab 100 mg Maintenance GLM-I-nonRsp-Golimumab 100 mg Maintenance
    Started
    156
    154
    154
    129
    230
    405
    Completed
    113
    111
    109
    88
    127
    189
    Not completed
    43
    43
    45
    41
    103
    216
         Other
    6
    12
    10
    11
    14
    34
         Lack of efficacy
    19
    17
    22
    18
    56
    124
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    1
         Adverse event, serious non-fatal
    17
    12
    12
    12
    30
    50
         Lost to follow-up
    1
    2
    1
    -
    3
    7
    Period 2
    Period 2 title
    Study Extension (Week 54-228)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Blinded up to the DBL for week 54 and resulting analyses were completed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo Extension
    Arm description
    Subjects entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of subjects remaining on placebo; those whose UC disease worsened (in the opinion of the investigator) had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received placebo subcutaneous injection administered every 4 weeks in study extension

    Arm title
    Golimumab 50 mg Extension
    Arm description
    Subjects entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened (in the opinion of the investigator) had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects receive golimumab 50 mg subcutaneous injection administered every 4 weeks in study extension or until dose increase following an increase in UC disease activity.

    Arm title
    Golimumab 100 mg Extension
    Arm description
    Subjects entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3, those whose UC disease worsened (in the opinion of the investigator) had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 100 milligram (mg)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.

    Arm title
    Golimumab 200 mg Extension
    Arm description
    Subjects entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 subjects remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Golimumab 200
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received golimumab 200 mg subcutaneous injection administered every 4 weeks in the study extension or until the dose was decreased to golimumab 100 mg.

    Number of subjects in period 2 [1]
    Placebo Extension Golimumab 50 mg Extension Golimumab 100 mg Extension Golimumab 200 mg Extension
    Started
    96
    93
    470
    7
    Completed
    16
    66
    288
    4
    Not completed
    80
    27
    182
    3
         Other
    63
    14
    87
    -
         Lack of efficacy
    5
    5
    34
    3
         Adverse event, serious fatal
    -
    -
    1
    -
         Adverse event, serious non-fatal
    10
    8
    54
    -
         Lost to follow-up
    2
    -
    6
    -
    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: Please note that the subjects enrolled in the study extension period is not the same as of Double bling period. Study extension period is extension of Double blind period with different number of subjects.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study. Subjects with loss of clinical response had their dose increased to golimumab 100 milligram (mg) subcutaneous injection administered every 4 weeks through Week 52.

    Reporting group title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study. Subjects with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.

    Reporting group title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18. Subjects with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52 (prior to protocol amendment 3).

    Reporting group title
    Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance
    Reporting group description
    Subjects in clinical response to placebo at Week 6 of induction study (C0524T16 or C0524T17) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study. These subjects were not randomized. Subjects with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

    Reporting group title
    PBO-I-nonRsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects not in clinical response to placebo at Week 6 induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52; not randomized.

    Reporting group title
    GLM-I-nonRsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects not in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52; not randomized.

    Reporting group values
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance PBO-I-nonRsp-Golimumab 100 mg Maintenance GLM-I-nonRsp-Golimumab 100 mg Maintenance Total
    Number of subjects
    156 154 154 129 230 405 1228
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0
        Adults (18-64 years)
    147 148 152 125 221 385 1178
        From 65 to 84 years
    9 6 2 4 9 20 50
        85 years and over
    0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    40.2 ± 14.05 41.4 ± 13.84 39.1 ± 13.11 38 ± 13.27 40.3 ± 12.67 41.2 ± 13.6 -
    Title for Gender
    Units: subjects
        Female
    81 77 65 68 99 138 528
        Male
    75 77 89 61 131 267 700

    End points

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    End points reporting groups
    Reporting group title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study. Subjects with loss of clinical response had their dose increased to golimumab 100 milligram (mg) subcutaneous injection administered every 4 weeks through Week 52.

    Reporting group title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study. Subjects with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.

    Reporting group title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18. Subjects with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52 (prior to protocol amendment 3).

    Reporting group title
    Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance
    Reporting group description
    Subjects in clinical response to placebo at Week 6 of induction study (C0524T16 or C0524T17) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study. These subjects were not randomized. Subjects with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.

    Reporting group title
    PBO-I-nonRsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects not in clinical response to placebo at Week 6 induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52; not randomized.

    Reporting group title
    GLM-I-nonRsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects not in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52; not randomized.
    Reporting group title
    Placebo Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of subjects remaining on placebo; those whose UC disease worsened (in the opinion of the investigator) had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.

    Reporting group title
    Golimumab 50 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened (in the opinion of the investigator) had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.

    Reporting group title
    Golimumab 100 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3, those whose UC disease worsened (in the opinion of the investigator) had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.

    Reporting group title
    Golimumab 200 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 subjects remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.

    Primary: Number of Subjects in Clinical Response Through Week 54

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    End point title
    Number of Subjects in Clinical Response Through Week 54 [1]
    End point description
    Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (>=) 30 percent and >= 3, with either decrease from induction baseline in rectal bleeding sub score of >= 1 or rectal bleeding sub score of 0 or 1. Subjects who lost clinical response prior to Week 54 were considered not to meet the endpoint. Mayo score is sum of 4 sub scores (i.e, stool frequency, rectal bleeding, endoscopic findings, physician’s global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12. 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    End point type
    Primary
    End point timeframe
    Induction Baseline, Week 0 through Week 54
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study.
    End point values
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects analysed
    154
    151
    151
    Units: Subjects
        number (not applicable)
    48
    71
    75
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 50 mg Maintenance
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.01
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Subjects With Clinical Remission at Both Week 30 and Week 54

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    End point title
    Number of Subjects With Clinical Remission at Both Week 30 and Week 54 [2]
    End point description
    Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (that is (i.e.) stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of subjects in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported. 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Week 30 and Week 54
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study.
    End point values
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects analysed
    154
    151
    151
    Units: Subjects
        number (not applicable)
    24
    35
    42
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 50 mg Maintenance
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.122
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.004
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Subjects With Mucosal Healing at Both Week 30 and Week 54

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    End point title
    Number of Subjects With Mucosal Healing at Both Week 30 and Week 54 [3]
    End point description
    Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of subjects with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported. 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Week 30 and Week 54
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study.
    End point values
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects analysed
    154
    151
    151
    Units: Subjects
        number (not applicable)
    41
    63
    64
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 50 mg Maintenance
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.011
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of subjects With Clinical Remission at Both Week 30 and 54 Among Subjects With Clinical Remission at Week 0 of Maintenance Study

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    End point title
    Number of subjects With Clinical Remission at Both Week 30 and 54 Among Subjects With Clinical Remission at Week 0 of Maintenance Study [4]
    End point description
    Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of subjects in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported. 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Week 30 and Week 54
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study.
    End point values
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects analysed
    54
    52
    54
    Units: Subjects
        number (not applicable)
    13
    19
    21
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 50 mg Maintenance
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.365
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.098
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Number of Subjects With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Subjects on Corticosteroids at Week 0 of Maintenance Study

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    End point title
    Number of Subjects With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Subjects on Corticosteroids at Week 0 of Maintenance Study [5]
    End point description
    Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician’s global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this measure.
    End point type
    Secondary
    End point timeframe
    Week 54
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study.
    End point values
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects analysed
    87
    78
    82
    Units: Subjects
        number (not applicable)
    16
    22
    19
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 50 mg Maintenance
    Number of subjects included in analysis
    165
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.279
    Method
    Cochran-Mantel-Haenszel
    Confidence interval
    Statistical analysis title
    Statistical Analysis 2
    Comparison groups
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance v GLM-I-Rsp-Golimumab 100 mg Maintenance
    Number of subjects included in analysis
    169
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.423
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to week 228
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study. Adverse events are presented through Week 54. Subjects with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For subjects with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.

    Reporting group title
    GLM-I-Rsp-Golimumab 50 mg Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study. Adverse events are presented through Week 54. Subjects with loss of clinical response will be re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52. For subjects with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.

    Reporting group title
    GLM-I-Rsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18. Adverse events are presented through Week 54. Subjects with loss of clinical response will be re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52 (prior to amendment 3). For subjects with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.

    Reporting group title
    GLM-I-Rsp-Placebo Maintenance to Golimumab 100 mg
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of an induction study (C0524T16 or C0524T17) and randomized to placebo in the maintenance study, and who had their dose increased to golimumab 100 mg on loss of clinical response (from the time of dose adjustment onward). Adverse events are presented from the time of dose adjustment onward up to Week 54.

    Reporting group title
    GLM-I-Rsp-Golimumab 50 mg Maintenance to Golimumab 100 mg
    Reporting group description
    Subjects in clinical response to golimumab at Week 6 of an induction study (C0524T16 or C0524T17) and randomized to golimumab 50 mg in the maintenance study, who had their dose increased to golimumab 100 mg on loss of clinical response. Adverse events are presented from the time of dose adjustment onward up to Week 54.

    Reporting group title
    GLM-I-Rsp-Golimumab 100 mg Maintenance to Golimumab 200 mg
    Reporting group description
    Subject in clinical response to golimumab at Week 6 of an induction study (C0524T16 or C0524T17) and randomized to golimumab 100 mg in the maintenance study, who had their dose increased to golimumab 200 mg on loss of clinical response (prior to amendment 3). Adverse events are presented from the time of dose adjustment onward up to Week 54.

    Reporting group title
    Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance
    Reporting group description
    Subjects in clinical response to placebo at Week 6 of induction study (C0524T16 or C0524T17) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study; not randomized. Adverse events are presented through Week 54. Subjects with loss of clinical response will have their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For subjects with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.

    Reporting group title
    PBO-I-nonRsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects not in clinical response to placebo at Week 6 induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study; not randomized. Adverse events are presented through Week 54.

    Reporting group title
    GLM-I-nonRsp-Golimumab 100 mg Maintenance
    Reporting group description
    Subjects not in clinical response to golimumab at Week 6 of induction study (C0524T16 or C0524T17) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study; not randomized. Adverse events are presented through Week 54.

    Reporting group title
    PBO-I-Rsp-Placebo Maintenance to Golimumab 100 mg
    Reporting group description
    Subjects in clinical response to placebo at Week 6 of an induction study (C0524T16 or C0524T17) and received placebo on entry into maintenance, and had their dose increased to golimumab 100 mg on loss of clinical response for subjects who dose adjusted to golimumab 100 mg; not randomized. Adverse events are presented from the time of dose adjustment onward up to Week 54.

    Reporting group title
    Placebo Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of subjects remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.

    Reporting group title
    Golimumab 50 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.

    Reporting group title
    Golimumab 100 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3, those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.

    Reporting group title
    Golimumab 200 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3, subjects remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to week 228.

    Reporting group title
    Placebo - Golimumab 50 mg Extension
    Reporting group description
    A single subject entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.

    Reporting group title
    Placebo-Golimumab 100 mg Extension
    Reporting group description
    Subjects entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.

    Reporting group title
    Golimumab 50 mg to 100 mg Extension
    Reporting group description
    Subjects entered the study extension at Week 54 receiving golimumab 50 mg and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.

    Reporting group title
    Golimumab 100 mg to 200 mg Extension
    Reporting group description
    Subjects entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment

    Serious adverse events
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance GLM-I-Rsp-Golimumab 50 mg Maintenance GLM-I-Rsp-Golimumab 100 mg Maintenance GLM-I-Rsp-Placebo Maintenance to Golimumab 100 mg GLM-I-Rsp-Golimumab 50 mg Maintenance to Golimumab 100 mg GLM-I-Rsp-Golimumab 100 mg Maintenance to Golimumab 200 mg Placebo induction responders (PBO-I-Rsp)-Placebo Maintenance PBO-I-nonRsp-Golimumab 100 mg Maintenance GLM-I-nonRsp-Golimumab 100 mg Maintenance PBO-I-Rsp-Placebo Maintenance to Golimumab 100 mg Placebo Extension Golimumab 50 mg Extension Golimumab 100 mg Extension Golimumab 200 mg Extension Placebo - Golimumab 50 mg Extension Placebo-Golimumab 100 mg Extension Golimumab 50 mg to 100 mg Extension Golimumab 100 mg to 200 mg Extension
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 156 (7.69%)
    13 / 154 (8.44%)
    22 / 154 (14.29%)
    8 / 76 (10.53%)
    6 / 25 (24.00%)
    1 / 14 (7.14%)
    7 / 129 (5.43%)
    34 / 230 (14.78%)
    63 / 405 (15.56%)
    7 / 56 (12.50%)
    8 / 96 (8.33%)
    11 / 93 (11.83%)
    91 / 469 (19.40%)
    1 / 7 (14.29%)
    0 / 1 (0.00%)
    7 / 28 (25.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    1
    2
    1
    0
    0
    0
    1
    4
    0
    1
    0
    7
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic Aneurysm Rupture
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adrenal Adenoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon Cancer Metastatic
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder Cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Huerthle Cell Carcinoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Epithelial Cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal Cancer Metastatic
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Cancer Metastatic
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    T-Cell Lymphoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    3 / 469 (0.64%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyserositis
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 154 (0.65%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression Suicidal
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressive Symptom
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental Disorder
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance Abuse
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical Dysplasia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 154 (0.65%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal Prolapse
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 154 (0.65%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental Poisoning
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional Hernia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Penetrating Abdominal Trauma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Complication
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    2 / 405 (0.49%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylopathy Traumatic
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Liver Function Test Abnormal
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    2 / 405 (0.49%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    1 / 96 (1.04%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    2 / 469 (0.43%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    2 / 96 (2.08%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    2 / 469 (0.43%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    4 / 4
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Infiltration
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    2 / 469 (0.43%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    1 / 96 (1.04%)
    1 / 93 (1.08%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia of Chronic Disease
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aplastic Anaemia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemolytic Anaemia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 154 (0.65%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Carotid Artery Stenosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Demyelination
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial Paresis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Sclerosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    1 / 19 (5.26%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve Root Compression
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    1 / 96 (1.04%)
    1 / 93 (1.08%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    2 / 469 (0.43%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Macular Fibrosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Hernia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    1 / 14 (7.14%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 154 (0.65%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    2 / 469 (0.43%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal Fissure
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    3 / 156 (1.92%)
    3 / 154 (1.95%)
    6 / 154 (3.90%)
    6 / 76 (7.89%)
    3 / 25 (12.00%)
    0 / 14 (0.00%)
    3 / 129 (2.33%)
    13 / 230 (5.65%)
    43 / 405 (10.62%)
    4 / 56 (7.14%)
    1 / 96 (1.04%)
    2 / 93 (2.15%)
    18 / 469 (3.84%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    2 / 28 (7.14%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 6
    0 / 7
    0 / 3
    0 / 0
    0 / 3
    0 / 13
    1 / 47
    0 / 4
    0 / 1
    0 / 2
    2 / 21
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon Dysplasia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    1 / 28 (3.57%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequent Bowel Movements
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    1 / 25 (4.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    1 / 76 (1.32%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    1 / 129 (0.78%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    3 / 469 (0.64%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    1 / 154 (0.65%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    1 / 230 (0.43%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus of Small Bowel
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    1 / 405 (0.25%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    0 / 469 (0.00%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 154 (0.00%)
    0 / 154 (0.00%)
    0 / 76 (0.00%)
    0 / 25 (0.00%)
    0 / 14 (0.00%)
    0 / 129 (0.00%)
    0 / 230 (0.00%)
    0 / 405 (0.00%)
    0 / 56 (0.00%)
    0 / 96 (0.00%)
    0 / 93 (0.00%)
    1 / 469 (0.21%)
    0 / 7 (0.00%)
    0 / 1 (0.00%)
    0 / 28 (0.00%)
    0 / 19 (0.00%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder Neck Obstruction