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    Clinical Trial Results:
    A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects with Moderately to Severely Active Crohn’s Disease

    Summary
    EudraCT number
    		 2010-022760-12
    Trial protocol
    		 DE   AT   GB   BE   CZ   IS   IE   FR   HU   NL   DK   ES   BG   IT  
    Global end of trial date
    01 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2020
    First version publication date
    16 Oct 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CNTO1275CRD3003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01369355
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Route 202, Raritan, United States, NJ 08869-0602
    Public contact
    Janssen Research & Development, LLC, Clinical Registry Group, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Janssen Research & Development, LLC, Clinical Registry Group, 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
    01 Oct 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to assess the efficacy, safety, pharmacokinetics, and immunogenicity of ustekinumab in subjects with moderately to severely active Crohn’s disease who had completed the 44-week maintenance study and who, in the opinion of the investigator, would benefit from continued treatment for up to 4 additional years of treatment with ustekinumab.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Known instances of non-conformance were documented and are not considered to have had an impact on the overall conclusions of this study. Safety evaluations were based upon the adverse events (AEs), serious adverse events (SAEs), clinical laboratory test results (i.e., hematology and serum chemistry), and physical examinations reported throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 6
    Country: Number of subjects enrolled
    Belgium: 31
    Country: Number of subjects enrolled
    Bulgaria: 21
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    Brazil: 12
    Country: Number of subjects enrolled
    Canada: 92
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    Germany: 84
    Country: Number of subjects enrolled
    Denmark: 4
    Country: Number of subjects enrolled
    Spain: 3
    Country: Number of subjects enrolled
    France: 64
    Country: Number of subjects enrolled
    United Kingdom: 67
    Country: Number of subjects enrolled
    Croatia: 4
    Country: Number of subjects enrolled
    Hungary: 64
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Iceland: 2
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Japan: 74
    Country: Number of subjects enrolled
    Korea, Republic of: 22
    Country: Number of subjects enrolled
    Netherlands: 36
    Country: Number of subjects enrolled
    New Zealand: 15
    Country: Number of subjects enrolled
    Poland: 36
    Country: Number of subjects enrolled
    Russian Federation: 17
    Country: Number of subjects enrolled
    Serbia: 19
    Country: Number of subjects enrolled
    United States: 495
    Country: Number of subjects enrolled
    South Africa: 31
    Worldwide total number of subjects
    1281
    EEA total number of subjects
    451
    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)
    1243
    From 65 to 84 years
    38
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of 1282 subjects enrolled, 1 was excluded from study before assignment to arm/group due to deviation from Good Clinical Practice at 1 study site. Hence 1281 subjects were analyzed. Total 397 subjects who were in clinical response to ustekinumab induction were randomized in maintenance study and considered as primary population.

    Pre-assignment
    Screening details
    		 A total of 1281 subjects started however 1084 subjects completed the study in the maintenance whereas out of 718 subjects, 395 completed LTE study.

    Period 1
    Period 1 title
    Week 0 - Week 44 (Maintenance)
    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
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
    Arm description
    		 Subjects (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo subcutaneously (SC) every 4 weeks (q4w) from Week 0 to 44 in the maintenance study.

    Arm title
    		 UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Arm description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo SC from Week 0 to 44 in the maintenance study.

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo and Ustekinumab SC 90 milligrams (mg) q8w from Week 0 to 44 in the maintenance study.

    Arm title
    		 UST-I-Rsp-UST-90 mg Q8W Maintenance
    Arm description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab SC 90 mg q12w from Week 0 to 44 in the maintenance study.

    Arm title
    		 Placebo (PBO)-I-Rsp - PBO Maintenance
    Arm description
    		 Subjects (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo SC q4w from Week 0 to 44 in the maintenance study.

    Arm title
    		 PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance
    Arm description
    		 Subjects (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received Ustekinumab SC 90 mg q8w from Week 0 to 44 in the maintenance study.

    Arm title
    		 UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
    Arm description
    		 Subjects (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use, Intravenous use
    Dosage and administration details
    Subjects received Ustekinumab SC 90 mg q8w from Week 0 to 44 in the maintenance study.

    Number of subjects in period 1
    		Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance Placebo (PBO)-I-Rsp - PBO Maintenance PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
    Started
    133
    132
    132
    123
    285
    476
    Completed
    102
    103
    101
    93
    131
    204
    Not completed
    31
    29
    31
    30
    154
    272
         Consent withdrawn by subject
    6
    2
    7
    6
    8
    22
         Adverse event, non-fatal
    9
    12
    6
    7
    14
    25
         Treatment assigned but never received
    -
    -
    1
    -
    -
    -
         Unspecified
    -
    -
    -
    -
    1
    -
         Lost to follow-up
    1
    -
    1
    2
    5
    6
         Lack of efficacy
    15
    14
    15
    15
    126
    217
         Protocol deviation
    -
    1
    1
    -
    -
    2
    Period 2
    Period 2 title
    Long-term Extension (Week 44-272)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 UST-I-Rsp Placebo Long Term Extension (LTE)
    Arm description
    		 Subjects who received placebo SC in the maintenance study, entered the long-term extension (LTE) and continued to receive placebo SC in the LTE study (Week 44 to 272).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects continued to receive placebo SC from Week 44 to 272 in the LTE study.

    Arm title
    		 UST-I-Rsp-UST 90 mg SC Q12W LTE
    Arm description
    		 Subjects entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects continued to receive Ustekinumab 90 mg SC q12w from Week 44 to 272 in the LTE study.

    Arm title
    		 UST-I-Rsp/Non-Rsp-UST 90 mg SC Q8W LTE
    Arm description
    		 Subjects entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ustekinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects continued to receive Ustekinumab 90 mg SC q8w from Week 44 to 272 in the LTE study.

    Number of subjects in period 2 [1]
    		UST-I-Rsp Placebo Long Term Extension (LTE) UST-I-Rsp-UST 90 mg SC Q12W LTE UST-I-Rsp/Non-Rsp-UST 90 mg SC Q8W LTE
    Started
    151
    213
    354
    Completed
    0
    107
    183
    Not completed
    151
    106
    171
         Adverse event, serious fatal
    -
    1
    3
         Physician decision
    1
    5
    11
         Consent withdrawn by subject
    12
    30
    47
         Adverse event, non-fatal
    15
    29
    53
         Subject unblinded to placebo
    110
    -
    -
         Study terminated by sponsor
    -
    1
    -
         Lost to follow-up
    1
    5
    9
         Subject started commercial stelara
    -
    8
    17
         Lack of efficacy
    12
    26
    29
         Protocol deviation
    -
    1
    2
    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: The number of subjects starting the LTE period (ends at 272 Weeks) is different from the maintenance study period (ends at Week 44) as the baseline study arms ends at Week 44 and participants were re-randomized in LTE period as per study design.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.

    Reporting group title
    UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.

    Reporting group title
    UST-I-Rsp-UST-90 mg Q8W Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.

    Reporting group title
    Placebo (PBO)-I-Rsp - PBO Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.

    Reporting group title
    PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance
    Reporting group description
    		 Subjects (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.

    Reporting group title
    UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
    Reporting group description
    		 Subjects (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.

    Reporting group values
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance Placebo (PBO)-I-Rsp - PBO Maintenance PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance Total
    Number of subjects
    		 133 132 132 123 285 476 1281
    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)
    		 129 125 126 118 279 466 1243
        From 65 to 84 years
    		 4 7 6 5 6 10 38
        85 years and over
    		 0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 39.5 ± 12.69 38.6 ± 13.65 37.9 ± 13.2 39.1 ± 12.46 39 ± 12.33 37.4 ± 12.5 -
    Title for Gender
    Units: subjects
        Female
    		 74 74 76 64 149 275 712
        Male
    		 59 58 56 59 136 201 569

    End points

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    End points reporting groups
    Reporting group title
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.

    Reporting group title
    UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.

    Reporting group title
    UST-I-Rsp-UST-90 mg Q8W Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.

    Reporting group title
    Placebo (PBO)-I-Rsp - PBO Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study; not randomized.

    Reporting group title
    PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance
    Reporting group description
    		 Subjects (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.

    Reporting group title
    UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
    Reporting group description
    		 Subjects (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
    Reporting group title
    UST-I-Rsp Placebo Long Term Extension (LTE)
    Reporting group description
    		 Subjects who received placebo SC in the maintenance study, entered the long-term extension (LTE) and continued to receive placebo SC in the LTE study (Week 44 to 272).

    Reporting group title
    UST-I-Rsp-UST 90 mg SC Q12W LTE
    Reporting group description
    		 Subjects entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).

    Reporting group title
    UST-I-Rsp/Non-Rsp-UST 90 mg SC Q8W LTE
    Reporting group description
    		 Subjects entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).

    Primary: Number of Subjects with Clinical Remission at Week 44

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    End point title
    		 Number of Subjects with Clinical Remission at Week 44 [1]
    End point description
    Clinical remission at Week 44 was defined as a Crohn’s Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn’s disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity. The primary efficacy analysis population in this study was randomized subjects (i.e., subjects who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
    End point type
    Primary
    End point timeframe
    Week 44
    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: As planned, the end point is not reporting statistics for all the arms of baseline period.
    End point values
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects analysed
    131
    129
    128
    Units: Subjects
        number (not applicable)
    47
    63
    68
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 milligram (mg) SC q12w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.04 [3]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [2] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [3] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 mg SC q8w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 = 0.005 [5]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [4] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [5] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.

    Secondary: Number of Subjects with Clinical Response at Week 44

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    End point title
    		 Number of Subjects with Clinical Response at Week 44 [6]
    End point description
    Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Subjects with a baseline CDAI score of >= 220 to less than or equal (<=) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity. The primary efficacy analysis population in this study was randomized subjects (i.e., subjects who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart.
    End point type
    Secondary
    End point timeframe
    Week 44
    Notes
    [6] - 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: As planned, the end point is not reporting statistics for all the arms of baseline period.
    End point values
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects analysed
    131
    129
    128
    Units: subjects
        number (not applicable)
    58
    75
    76
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 milligram (mg) SC q12w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.033 [8]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [7] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [8] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 mg SC q8w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.018 [10]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [9] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [10] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.

    Secondary: Number of Subjects in Clinical Remission at Week 44 Among Subjects in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study

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    End point title
    		 Number of Subjects in Clinical Remission at Week 44 Among Subjects in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study [11]
    End point description
    Clinical remission at week 44 was defined as a CDAI score of < 150 points among subjects in clinical remission to Ustekinumab at week 0 of maintenance study. Analysis population included all randomized participants after the study was restarted (who were in clinical remission at Week 0 of maintenance study). Here 'N' (number of subjects analyzed) signifies those subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 44
    Notes
    [11] - 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: As planned, the end point is not reporting statistics for all the arms of baseline period.
    End point values
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects analysed
    79
    78
    78
    Units: subjects
        number (not applicable)
    36
    44
    52
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 mg SC q8w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.007 [13]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [12] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by Ustekinumab induction dose and the induction study.
    [13] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 milligram (mg) SC q12w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [14]
    P-value
    		 = 0.189 [15]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [14] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [15] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.

    Secondary: Number of Subjects with Corticosteroid-free Remission at Week 44

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    End point title
    		 Number of Subjects with Corticosteroid-free Remission at Week 44 [16]
    End point description
    Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44. The primary efficacy analysis population in this study was randomized subjects (i.e., subjects who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart. Here 'N' (number of subjects analyzed) signifies number of subjects evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Week 44
    Notes
    [16] - 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: As planned, the end point is not reporting statistics for all the arms of baseline period.
    End point values
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects analysed
    131
    129
    128
    Units: subjects
        number (not applicable)
    39
    55
    60
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 milligram (mg) SC q12w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects included in analysis
    259
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [17]
    P-value
    		 = 0.035 [18]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [17] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [18] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 mg SC q8w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Number of subjects included in analysis
    260
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [19]
    P-value
    		 = 0.004 [20]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [19] - 2-sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission at Week 0, Ustekinumab induction dose and the induction study.
    [20] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.

    Secondary: Number of Subjects in Clinical Remission at Week 44 in the Subset of Subjects who were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy

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    End point title
    		 Number of Subjects in Clinical Remission at Week 44 in the Subset of Subjects who were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy [21]
    End point description
    Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of subjects who were refractory or Intolerant to tumor necrosis factor antagonist therapy. The primary efficacy analysis population in this study was randomized subjects (i.e., subjects who were in clinical response to ustekinumab induction dosing at Week 8 from one of the induction studies CRD3001 and CRD3002) after study restart. Here 'N' (number of subjects analyzed) signifies subset of participants at baseline who were refractory or intolerant to tumor necrosis Factor (TNF) antagonist therapy.
    End point type
    Secondary
    End point timeframe
    Week 44
    Notes
    [21] - 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: As planned, the end point is not reporting statistics for all the arms of baseline period.
    End point values
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects analysed
    61
    57
    56
    Units: subjects
        number (not applicable)
    16
    22
    23
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 milligram (mg) SC q12w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Q8W Maintenance
    Number of subjects included in analysis
    117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [22]
    P-value
    		 = 0.14 [23]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [22] - 2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and Ustekinumab induction dose.
    [23] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.
    Statistical analysis title
    		 Placebo SC, Ustekinumab 90 mg SC q8w
    Comparison groups
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance v UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [24]
    P-value
    		 = 0.102 [25]
    Method
    		 Cochran-Mantel-Haenszel chi-square test
    Confidence interval
    Notes
    [24] - 2 sided Cochran-Mantel-Haenszel chi-square test, stratified by clinical remission status at Week 0 and Ustekinumab induction dose.
    [25] - A fixed sequence testing procedure was used to control alpha at 0.05 over the outcome measures.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 272
    Adverse event reporting additional description
    Safety was analyzed for all treated subjects who received at least 1 administration of study agent in the maintenance (Week 0-44) and LTE study (Week 44-272).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).

    Reporting group title
    UST-I-Rsp -PBO Maintenance-UST-90mg SC Q8W Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to Ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).

    Reporting group title
    UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events from the time of loss of response onward).

    Reporting group title
    UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q12w and had dose adjustment to Ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).

    Reporting group title
    UST-I-Rsp-UST-90 mg Q8W Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).

    Reporting group title
    UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8 weeks and remained on Ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).

    Reporting group title
    Placebo (PBO)-I-Rsp PBO Maintenance
    Reporting group description
    		 Subjects (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.

    Reporting group title
    PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance
    Reporting group description
    		 Subjects (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.

    Reporting group title
    UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance
    Reporting group description
    		 Subjects (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.

    Reporting group title
    Placebo Long Term Extension (LTE)
    Reporting group description
    		 Subjects who received placebo SC in the maintenance study, entered the LTE and continued to receive placebo SC in the LTE study (Week 44 to 272).

    Reporting group title
    UST 90 mg SC Q12W LTE
    Reporting group description
    		 Subjects entered the LTE and continued to receive ustekinumab 90 mg SC q12w in the LTE study (Week 44 to 272).

    Reporting group title
    UST 90 mg SC Q8W LTE
    Reporting group description
    		 Subjects entered the LTE and continued to receive ustekinumab 90 mg SC q8w in the LTE study (Week 44 to 272).

    Serious adverse events
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp -PBO Maintenance-UST-90mg SC Q8W Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance Placebo (PBO)-I-Rsp PBO Maintenance PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    22 / 133 (16.54%)
    7 / 51 (13.73%)
    16 / 132 (12.12%)
    5 / 29 (17.24%)
    13 / 131 (9.92%)
    6 / 29 (20.69%)
    19 / 123 (15.45%)
    47 / 285 (16.49%)
    77 / 476 (16.18%)
    26 / 151 (17.22%)
    68 / 213 (31.92%)
    99 / 354 (27.97%)
         number of deaths (all causes)
    1
    1
    1
    0
    0
    0
    0
    0
    2
    0
    2
    4
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Neoplasm of Thyroid Gland
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Chronic Myeloid Leukaemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Endometrial Adenocarcinoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Fibroadenoma of Breast
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Lentigo Maligna
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Meningioma
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Ovarian Adenoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Pancreatic Carcinoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Papillary Thyroid Cancer
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    0 / 354 (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 / 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
    Renal Cell Carcinoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Seminoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Small Intestine Adenocarcinoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Uterine Leiomyoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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 / 1
    0 / 1
         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
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Aortic Dissection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Aortic Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 2
         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
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    2 / 476 (0.42%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         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
    Essential Hypertension
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Hypertension
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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 / 1
         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
    Hypertensive Urgency
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Surgical and medical procedures
    Abdominal Hernia Repair
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Ileostomy Closure
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Knee Arthroplasty
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Pelvic Pouch Procedure
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Rotator Cuff Repair
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    3 / 213 (1.41%)
    3 / 354 (0.85%)
         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 / 3
    1 / 3
         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
    Premature Delivery
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Premature Labour
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    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
    Chest Pain
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Dysplasia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Incarcerated Hernia
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    2 / 476 (0.42%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 2
         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
    Oedema Peripheral
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Pyrexia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         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 / 2
         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
    Sudden Death
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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 / 1
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Social circumstances
    Breast Prosthesis User
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Miscarriage of Partner
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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 / 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
    Substance Abuser
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Bartholin's Cyst
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Female Genital Tract Fistula
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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 / 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
    Menorrhagia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Pelvic Congestion
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Uterine Prolapse
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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 / 1
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 4
         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
    Nasal Polyps
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Pulmonary Embolism
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    1 / 213 (0.47%)
    0 / 354 (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 / 1
    0 / 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
    Pulmonary Granuloma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Pulmonary Haematoma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    1 / 476 (0.21%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Suicidal Ideation
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Suicide Attempt
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Cholecystitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    1 / 29 (3.45%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    3 / 354 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 3
         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
    Investigations
    Blood Electrolytes Abnormal
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Electrocardiogram Abnormal
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Faecal Volume Increased
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Hepatic Enzyme Increased
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Troponin Increased
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Injury, poisoning and procedural complications
    Alcohol Poisoning
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Allergic Transfusion Reaction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Anastomotic Haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Anastomotic Leak
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Concussion
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Contusion
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Forearm Fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Gastrointestinal Anastomotic Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Heat Stroke
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Humerus Fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Intestinal Anastomosis Complication
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
    0 / 0
    0 / 1
         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
    Ligament Rupture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Ligament Sprain
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Muscle Injury
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Procedural Intestinal Perforation
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    0 / 354 (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 / 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
    Procedural Pain
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
         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
    Seroma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Sternal Injury
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Thoracic Vertebral Fracture
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Congenital, familial and genetic disorders
    Fibrous Dysplasia of Bone
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
    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
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    2 / 213 (0.94%)
    0 / 354 (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 / 1
    0 / 2
    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 / 1
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Aortic Valve Incompetence
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Atrial Fibrillation
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Cardio-Respiratory Arrest
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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 / 1
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Coronary Artery Disease
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    2 / 213 (0.94%)
    0 / 354 (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
         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
    Myocardial Infarction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
    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
    Nervous system disorders
    Cerebral Infarction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Dementia with Lewy Bodies
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Headache
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Idiopathic Intracranial Hypertension
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 2
         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
    Intracranial Aneurysm
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Ischaemic Stroke
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Migraine
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Paraesthesia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Radiculopathy
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Seizure
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Subarachnoid Haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
         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
    Syncope
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         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 / 2
         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
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Lymphadenitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Eye disorders
    Chorioretinopathy
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Retinal Detachment
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Strabismus
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Gastrointestinal disorders
    Abdominal Adhesions
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Abdominal Discomfort
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Abdominal Hernia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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 / 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
    Abdominal Pain
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    2 / 151 (1.32%)
    1 / 213 (0.47%)
    5 / 354 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 2
    0 / 1
    0 / 6
         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
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Anal Fissure
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Anal Fistula
         subjects affected / exposed
    2 / 133 (1.50%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    2 / 285 (0.70%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Colon Dysplasia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Constipation
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
    0 / 0
    0 / 1
         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
    Crohn's Disease
         subjects affected / exposed
    7 / 133 (5.26%)
    4 / 51 (7.84%)
    5 / 132 (3.79%)
    3 / 29 (10.34%)
    4 / 131 (3.05%)
    3 / 29 (10.34%)
    6 / 123 (4.88%)
    15 / 285 (5.26%)
    30 / 476 (6.30%)
    12 / 151 (7.95%)
    17 / 213 (7.98%)
    32 / 354 (9.04%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 4
    0 / 6
    0 / 4
    0 / 5
    0 / 4
    0 / 6
    0 / 15
    0 / 31
    0 / 14
    2 / 22
    0 / 46
         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
    Cyclic Vomiting Syndrome
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
         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
    Diarrhoea
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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 / 1
    0 / 1
         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
    Dyspepsia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Dysphagia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Enterocutaneous Fistula
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Enterovesical Fistula
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Epiploic Appendagitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Faecaloma
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    2 / 285 (0.70%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fistula of Small Intestine
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Gastritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    3 / 213 (1.41%)
    0 / 354 (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 / 3
    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
    Haematemesis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Haematochezia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    1 / 213 (0.47%)
    0 / 354 (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 / 1
    0 / 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
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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 / 1
         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
    Ileal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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 / 1
         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
    Inflammatory Bowel Disease
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Intestinal Obstruction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    1 / 213 (0.47%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 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
    Intestinal Perforation
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Intestinal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    2 / 476 (0.42%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         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 / 2
         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
    Large Intestinal Obstruction
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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 / 1
    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
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    2 / 131 (1.53%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Large Intestine Polyp
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Mallory-Weiss Syndrome
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Melaena
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Oesophageal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Rectal Prolapse
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Rectal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    2 / 285 (0.70%)
    10 / 476 (2.10%)
    4 / 151 (2.65%)
    6 / 213 (2.82%)
    10 / 354 (2.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 0
    0 / 2
    0 / 0
    0 / 1
    0 / 3
    0 / 12
    0 / 5
    0 / 6
    0 / 12
         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
    Small Intestinal Perforation
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Small Intestinal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    1 / 151 (0.66%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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 / 1
    0 / 1
    0 / 1
         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
    Tooth Impacted
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Umbilical Hernia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 2
         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
    Skin and subcutaneous tissue disorders
    Pustular Psoriasis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Stevens-Johnson Syndrome
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    End Stage Renal Disease
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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 / 1
    Nephrolithiasis
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    2 / 213 (0.94%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    0 / 1
         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
    Renal Colic
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Renal Tubular Necrosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Ureterolithiasis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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 / 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
    Urinary Retention
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Back Pain
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Costochondritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Dactylitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Fibromyalgia
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Intervertebral Disc Space Narrowing
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Lumbar Spinal Stenosis
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Osteoarthritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    3 / 354 (0.85%)
         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 / 4
         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
    Polyarthritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    1 / 29 (3.45%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Spinal Stenosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    2 / 213 (0.94%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 2
    1 / 1
         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
    Abdominal Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Abscess Intestinal
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Acarodermatitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Acute Sinusitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Anal Abscess
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    3 / 285 (1.05%)
    3 / 476 (0.63%)
    1 / 151 (0.66%)
    6 / 213 (2.82%)
    3 / 354 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 3
    0 / 3
    0 / 1
    0 / 7
    0 / 5
         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
    Anal Fistula Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Appendicitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    2 / 132 (1.52%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
         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
    Bacteraemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Campylobacter Gastroenteritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Cellulitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    2 / 213 (0.94%)
    1 / 354 (0.28%)
         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 / 1
         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
    Clostridium Difficile Colitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    1 / 123 (0.81%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Cytomegalovirus Colitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    0 / 354 (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 / 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
    Cytomegalovirus Viraemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Device Related Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Diverticulitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    2 / 354 (0.56%)
         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 / 2
         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
    Gastroenteritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    1 / 476 (0.21%)
    1 / 151 (0.66%)
    1 / 213 (0.47%)
    2 / 354 (0.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         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
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis Infectious Mononucleosis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Influenza
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Liver Abscess
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    0 / 354 (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 / 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
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Mastitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Myringitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Ophthalmic Herpes Zoster
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    Parainfluenzae Virus Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Perirectal Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         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 / 2
         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
    Peritonitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    1 / 29 (3.45%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Pneumonia
         subjects affected / exposed
    2 / 133 (1.50%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    2 / 213 (0.94%)
    2 / 354 (0.56%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 2
    1 / 2
         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
    Pneumonia Pneumococcal
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Pneumonia Staphylococcal
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Postoperative Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
    0 / 0
    0 / 1
         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
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (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
         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
    Pseudomembranous Colitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Pyelonephritis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    2 / 354 (0.56%)
         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 / 2
         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
    Rectal Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    1 / 285 (0.35%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    0 / 354 (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 / 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
    Sepsis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    1 / 354 (0.28%)
         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
    1 / 1
    0 / 1
         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
    Septic Shock
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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 / 1
    Sialoadenitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Tonsillitis
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Tubo-Ovarian Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Vaginal Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Vascular Device Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Viral Infection
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound Abscess
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    2 / 213 (0.94%)
    3 / 354 (0.85%)
         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 / 3
         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
    Electrolyte Imbalance
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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
         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
    Hypokalaemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    1 / 151 (0.66%)
    0 / 213 (0.00%)
    1 / 354 (0.28%)
         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 / 1
    0 / 0
    0 / 1
         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
    Hyponatraemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    0 / 285 (0.00%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    0 / 354 (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
         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
    Malnutrition
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    2 / 285 (0.70%)
    0 / 476 (0.00%)
    0 / 151 (0.00%)
    0 / 213 (0.00%)
    0 / 354 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance UST-I-Rsp -PBO Maintenance-UST-90mg SC Q8W Maintenance UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance UST-I-Rsp-UST-90 mg Q8W Maintenance UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance Placebo (PBO)-I-Rsp PBO Maintenance PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance Placebo Long Term Extension (LTE) UST 90 mg SC Q12W LTE UST 90 mg SC Q8W LTE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 133 (70.68%)
    34 / 51 (66.67%)
    88 / 132 (66.67%)
    20 / 29 (68.97%)
    84 / 131 (64.12%)
    18 / 29 (62.07%)
    82 / 123 (66.67%)
    160 / 285 (56.14%)
    275 / 476 (57.77%)
    83 / 151 (54.97%)
    162 / 213 (76.06%)
    293 / 354 (82.77%)
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 133 (0.75%)
    1 / 51 (1.96%)
    1 / 132 (0.76%)
    2 / 29 (6.90%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    2 / 123 (1.63%)
    1 / 285 (0.35%)
    5 / 476 (1.05%)
    5 / 151 (3.31%)
    5 / 213 (2.35%)
    5 / 354 (1.41%)
         occurrences all number
    1
    1
    1
    2
    1
    0
    2
    1
    6
    5
    5
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 133 (11.28%)
    6 / 51 (11.76%)
    15 / 132 (11.36%)
    2 / 29 (6.90%)
    15 / 131 (11.45%)
    2 / 29 (6.90%)
    16 / 123 (13.01%)
    21 / 285 (7.37%)
    41 / 476 (8.61%)
    12 / 151 (7.95%)
    19 / 213 (8.92%)
    40 / 354 (11.30%)
         occurrences all number
    40
    7
    19
    2
    23
    2
    20
    23
    58
    14
    25
    62
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 133 (0.00%)
    0 / 51 (0.00%)
    5 / 132 (3.79%)
    1 / 29 (3.45%)
    3 / 131 (2.29%)
    0 / 29 (0.00%)
    5 / 123 (4.07%)
    6 / 285 (2.11%)
    11 / 476 (2.31%)
    2 / 151 (1.32%)
    15 / 213 (7.04%)
    17 / 354 (4.80%)
         occurrences all number
    0
    0
    5
    1
    4
    0
    6
    6
    11
    2
    23
    21
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 133 (4.51%)
    2 / 51 (3.92%)
    8 / 132 (6.06%)
    1 / 29 (3.45%)
    6 / 131 (4.58%)
    0 / 29 (0.00%)
    9 / 123 (7.32%)
    11 / 285 (3.86%)
    15 / 476 (3.15%)
    8 / 151 (5.30%)
    13 / 213 (6.10%)
    29 / 354 (8.19%)
         occurrences all number
    6
    2
    8
    1
    6
    0
    10
    14
    16
    8
    14
    34
    Injection Site Erythema
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    1 / 132 (0.76%)
    1 / 29 (3.45%)
    7 / 131 (5.34%)
    1 / 29 (3.45%)
    2 / 123 (1.63%)
    5 / 285 (1.75%)
    7 / 476 (1.47%)
    1 / 151 (0.66%)
    7 / 213 (3.29%)
    7 / 354 (1.98%)
         occurrences all number
    0
    1
    1
    1
    14
    2
    2
    5
    11
    1
    7
    17
    Pyrexia
         subjects affected / exposed
    11 / 133 (8.27%)
    2 / 51 (3.92%)
    11 / 132 (8.33%)
    3 / 29 (10.34%)
    9 / 131 (6.87%)
    1 / 29 (3.45%)
    12 / 123 (9.76%)
    16 / 285 (5.61%)
    25 / 476 (5.25%)
    9 / 151 (5.96%)
    19 / 213 (8.92%)
    19 / 354 (5.37%)
         occurrences all number
    18
    2
    23
    8
    11
    1
    25
    16
    30
    10
    25
    26
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    17 / 133 (12.78%)
    3 / 51 (5.88%)
    12 / 132 (9.09%)
    5 / 29 (17.24%)
    11 / 131 (8.40%)
    1 / 29 (3.45%)
    15 / 123 (12.20%)
    23 / 285 (8.07%)
    38 / 476 (7.98%)
    16 / 151 (10.60%)
    38 / 213 (17.84%)
    68 / 354 (19.21%)
         occurrences all number
    26
    3
    17
    7
    13
    1
    16
    27
    44
    17
    51
    111
    Abdominal Pain Upper
         subjects affected / exposed
    3 / 133 (2.26%)
    1 / 51 (1.96%)
    4 / 132 (3.03%)
    1 / 29 (3.45%)
    2 / 131 (1.53%)
    2 / 29 (6.90%)
    5 / 123 (4.07%)
    8 / 285 (2.81%)
    15 / 476 (3.15%)
    8 / 151 (5.30%)
    11 / 213 (5.16%)
    22 / 354 (6.21%)
         occurrences all number
    5
    1
    4
    1
    2
    3
    8
    9
    17
    10
    11
    25
    Constipation
         subjects affected / exposed
    4 / 133 (3.01%)
    1 / 51 (1.96%)
    6 / 132 (4.55%)
    2 / 29 (6.90%)
    3 / 131 (2.29%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    6 / 285 (2.11%)
    10 / 476 (2.10%)
    0 / 151 (0.00%)
    9 / 213 (4.23%)
    22 / 354 (6.21%)
         occurrences all number
    4
    1
    11
    2
    3
    0
    0
    7
    10
    0
    9
    30
    Crohn's Disease
         subjects affected / exposed
    12 / 133 (9.02%)
    5 / 51 (9.80%)
    12 / 132 (9.09%)
    3 / 29 (10.34%)
    12 / 131 (9.16%)
    2 / 29 (6.90%)
    13 / 123 (10.57%)
    17 / 285 (5.96%)
    40 / 476 (8.40%)
    25 / 151 (16.56%)
    44 / 213 (20.66%)
    80 / 354 (22.60%)
         occurrences all number
    12
    5
    12
    4
    13
    2
    20
    19
    54
    34
    62
    113
    Diarrhoea
         subjects affected / exposed
    7 / 133 (5.26%)
    2 / 51 (3.92%)
    11 / 132 (8.33%)
    1 / 29 (3.45%)
    5 / 131 (3.82%)
    0 / 29 (0.00%)
    11 / 123 (8.94%)
    10 / 285 (3.51%)
    12 / 476 (2.52%)
    11 / 151 (7.28%)
    30 / 213 (14.08%)
    50 / 354 (14.12%)
         occurrences all number
    11
    2
    11
    1
    9
    0
    12
    11
    13
    14
    42
    67
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 133 (1.50%)
    2 / 51 (3.92%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    2 / 123 (1.63%)
    4 / 285 (1.40%)
    7 / 476 (1.47%)
    2 / 151 (1.32%)
    11 / 213 (5.16%)
    15 / 354 (4.24%)
         occurrences all number
    2
    2
    1
    0
    1
    0
    3
    4
    7
    4
    11
    15
    Nausea
         subjects affected / exposed
    9 / 133 (6.77%)
    3 / 51 (5.88%)
    10 / 132 (7.58%)
    3 / 29 (10.34%)
    4 / 131 (3.05%)
    1 / 29 (3.45%)
    12 / 123 (9.76%)
    15 / 285 (5.26%)
    46 / 476 (9.66%)
    12 / 151 (7.95%)
    23 / 213 (10.80%)
    34 / 354 (9.60%)
         occurrences all number
    12
    3
    10
    4
    4
    1
    16
    18
    53
    13
    32
    43
    Vomiting
         subjects affected / exposed
    9 / 133 (6.77%)
    3 / 51 (5.88%)
    5 / 132 (3.79%)
    2 / 29 (6.90%)
    4 / 131 (3.05%)
    2 / 29 (6.90%)
    5 / 123 (4.07%)
    6 / 285 (2.11%)
    33 / 476 (6.93%)
    2 / 151 (1.32%)
    14 / 213 (6.57%)
    26 / 354 (7.34%)
         occurrences all number
    11
    4
    7
    2
    4
    2
    5
    6
    46
    2
    26
    34
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 133 (2.26%)
    1 / 51 (1.96%)
    4 / 132 (3.03%)
    0 / 29 (0.00%)
    7 / 131 (5.34%)
    0 / 29 (0.00%)
    6 / 123 (4.88%)
    9 / 285 (3.16%)
    26 / 476 (5.46%)
    8 / 151 (5.30%)
    13 / 213 (6.10%)
    24 / 354 (6.78%)
         occurrences all number
    4
    1
    5
    0
    7
    0
    7
    10
    28
    8
    17
    31
    Oropharyngeal Pain
         subjects affected / exposed
    4 / 133 (3.01%)
    2 / 51 (3.92%)
    2 / 132 (1.52%)
    2 / 29 (6.90%)
    3 / 131 (2.29%)
    1 / 29 (3.45%)
    2 / 123 (1.63%)
    8 / 285 (2.81%)
    13 / 476 (2.73%)
    0 / 151 (0.00%)
    10 / 213 (4.69%)
    12 / 354 (3.39%)
         occurrences all number
    4
    3
    3
    2
    4
    1
    2
    8
    13
    0
    11
    19
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 133 (0.75%)
    3 / 51 (5.88%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    2 / 131 (1.53%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    5 / 285 (1.75%)
    7 / 476 (1.47%)
    2 / 151 (1.32%)
    6 / 213 (2.82%)
    9 / 354 (2.54%)
         occurrences all number
    2
    4
    2
    0
    2
    1
    0
    5
    7
    2
    6
    9
    Rash
         subjects affected / exposed
    5 / 133 (3.76%)
    2 / 51 (3.92%)
    4 / 132 (3.03%)
    1 / 29 (3.45%)
    7 / 131 (5.34%)
    2 / 29 (6.90%)
    5 / 123 (4.07%)
    5 / 285 (1.75%)
    22 / 476 (4.62%)
    5 / 151 (3.31%)
    12 / 213 (5.63%)
    20 / 354 (5.65%)
         occurrences all number
    5
    2
    4
    2
    7
    3
    5
    5
    24
    5
    16
    29
    Urticaria
         subjects affected / exposed
    1 / 133 (0.75%)
    0 / 51 (0.00%)
    2 / 132 (1.52%)
    0 / 29 (0.00%)
    0 / 131 (0.00%)
    2 / 29 (6.90%)
    2 / 123 (1.63%)
    2 / 285 (0.70%)
    3 / 476 (0.63%)
    0 / 151 (0.00%)
    1 / 213 (0.47%)
    2 / 354 (0.56%)
         occurrences all number
    1
    0
    2
    0
    0
    2
    2
    2
    3
    0
    1
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 133 (0.75%)
    1 / 51 (1.96%)
    2 / 132 (1.52%)
    2 / 29 (6.90%)
    0 / 131 (0.00%)
    0 / 29 (0.00%)
    0 / 123 (0.00%)
    4 / 285 (1.40%)
    3 / 476 (0.63%)
    1 / 151 (0.66%)
    6 / 213 (2.82%)
    12 / 354 (3.39%)
         occurrences all number
    1
    1
    2
    2
    0
    0
    0
    6
    3
    1
    6
    12
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    18 / 133 (13.53%)
    6 / 51 (11.76%)
    22 / 132 (16.67%)
    5 / 29 (17.24%)
    18 / 131 (13.74%)
    3 / 29 (10.34%)
    23 / 123 (18.70%)
    29 / 285 (10.18%)
    49 / 476 (10.29%)
    11 / 151 (7.28%)
    27 / 213 (12.68%)
    40 / 354 (11.30%)
         occurrences all number
    24
    7
    25
    5
    20
    3
    34
    38
    55
    12
    37
    76
    Arthritis
         subjects affected / exposed
    3 / 133 (2.26%)
    0 / 51 (0.00%)
    3 / 132 (2.27%)
    0 / 29 (0.00%)
    1 / 131 (0.76%)
    0 / 29 (0.00%)
    8 / 123 (6.50%)
    7 / 285 (2.46%)
    3 / 476 (0.63%)
    1 / 151 (0.66%)
    1 / 213 (0.47%)
    4 / 354 (1.13%)
         occurrences all number
    3
    0
    3
    0
    1
    0
    9
    8
    3
    2
    1
    4
    Back Pain
         subjects affected / exposed
    6 / 133 (4.51%)
    2 / 51 (3.92%)
    5 / 132 (3.79%)
    1 / 29 (3.45%)
    6 / 131 (4.58%)
    3 / 29 (10.34%)
    2 / 123 (1.63%)
    12 / 285 (4.21%)
    15 / 476 (3.15%)
    13 / 151 (8.61%)
    18 / 213 (8.45%)
    48 / 354 (13.56%)
         occurrences all number
    6
    2
    5
    1
    8
    3
    2
    12
    21
    13
    23
    53
    Pain in Extremity
         subjects affected / exposed
    0 / 133 (0.00%)
    1 / 51 (1.96%)
    0 / 132 (0.00%)
    1 / 29 (3.45%)
    5 / 131 (3.82%)
    1 / 29 (3.45%)
    0 / 123 (0.00%)
    4 / 285 (1.40%)
    6 / 476 (1.26%)
    1 / 151 (0.66%)
    9 / 213 (4.23%)
    18 / 354 (5.08%)
         occurrences all number
    0
    1
    0
    1
    5
    1
    0
    4
    7
    2
    9
    21
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 133 (3.01%)
    3 / 51 (5.88%)
    1 / 132 (0.76%)
    0 / 29 (0.00%)
    6 / 131 (4.58%)
    0 / 29 (0.00%)
    3 / 123 (2.44%)
    5 / 285 (1.75%)
    7 / 476 (1.47%)
    4 / 151 (2.65%)
    13 / 213 (6.10%)
    30 / 354 (8.47%)
         occurrences all number
    4
    4
    1
    0
    8
    0
    3
    5
    7
    4
    17
    39
    Gastroenteritis
         subjects affected / exposed
    5 / 133 (3.76%)
    1 / 51 (1.96%)
    3 / 132 (2.27%)
    0 / 29 (0.00%)
    4 / 131 (3.05%)
    0 / 29 (0.00%)
    4 / 123 (3.25%)
    8 / 285 (2.81%)
    18 / 476 (3.78%)
    7 / 151 (4.64%)
    21 / 213 (9.86%)
    41 / 354 (11.58%)
         occurrences all number
    6
    1
    3
    0
    5
    0
    4
    11
    22
    7
    27
    46
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 133 (0.75%)
    3 / 51 (5.88%)
    4 / 132 (3.03%)
    0 / 29 (0.00%)
    4 / 131 (3.05%)
    2 / 29 (6.90%)
    5 / 123 (4.07%)
    6 / 285 (2.11%)
    6 / 476 (1.26%)
    2 / 151 (1.32%)
    11 / 213 (5.16%)
    12 / 354 (3.39%)
         occurrences all number
    1
    4
    4
    0
    5
    2
    6
    7
    8
    2
    12
    14
    Influenza
         subjects affected / exposed
    4 / 133 (3.01%)
    1 / 51 (1.96%)
    8 / 132 (6.06%)
    1 / 29 (3.45%)
    5 / 131 (3.82%)
    1 / 29 (3.45%)
    4 / 123 (3.25%)
    9 / 285 (3.16%)
    8 / 476 (1.68%)
    4 / 151 (2.65%)
    25 / 213 (11.74%)
    37 / 354 (10.45%)
         occurrences all number
    4
    1
    9
    1
    7
    1
    4
    9
    8
    5
    44
    44
    Nasopharyngitis
         subjects affected / exposed
    10 / 133 (7.52%)
    4 / 51 (7.84%)
    17 / 132 (12.88%)
    4 / 29 (13.79%)
    14 / 131 (10.69%)
    0 / 29 (0.00%)
    15 / 123 (12.20%)
    32 / 285 (11.23%)
    52 / 476 (10.92%)
    16 / 151 (10.60%)
    54 / 213 (25.35%)
    100 / 354 (28.25%)
         occurrences all number
    11
    8
    24
    5
    22
    0
    20
    44
    70
    21
    130
    209
    Pharyngitis Streptococcal
         subjects affected / exposed
    2 / 133 (1.50%)
    0 / 51 (0.00%)
    0 / 132 (0.00%)
    1 / 29 (3.45%)
    0 / 131 (0.00%)
    2 / 29 (6.90%)
    2 / 123 (1.63%)
    3 / 285 (1.05%)
    1 / 476 (0.21%)
    0 / 151 (0.00%)
    2 / 213 (0.94%)
    3 / 354 (0.85%)
         occurrences all number
    2
    0
    0
    1
    0
    2
    2
    3
    1
    0
    2
    4
    Sinusitis
         subjects affected / exposed
    2 / 133 (1.50%)
    0 / 51 (0.00%)
    6 / 132 (4.55%)
    2 / 29 (6.90%)
    4 / 131 (3.05%)
    2 / 29 (6.90%)
    5 / 123 (4.07%)
    12 / 285 (4.21%)
    17 / 476 (3.57%)
    8 / 151 (5.30%)
    19 / 213 (8.92%)
    36 / 354 (10.17%)
         occurrences all number
    2
    0
    8
    2
    4
    2
    6
    13
    22
    9
    24
    53
    Upper Respiratory Tract Infection
         subjects affected / exposed
    21 / 133 (15.79%)
    1 / 51 (1.96%)
    9 / 132 (6.82%)
    0 / 29 (0.00%)
    13 / 131 (9.92%)
    1 / 29 (3.45%)
    7 / 123 (5.69%)
    25 / 285 (8.77%)
    33 / 476 (6.93%)
    14 / 151 (9.27%)
    40 / 213 (18.78%)
    62 / 354 (17.51%)
         occurrences all number
    25
    1
    12
    0
    14
    1
    9
    28
    40
    18
    69
    100
    Urinary Tract Infection
         subjects affected / exposed
    3 / 133 (2.26%)
    1 / 51 (1.96%)
    9 / 132 (6.82%)
    1 / 29 (3.45%)
    4 / 131 (3.05%)
    1 / 29 (3.45%)
    7 / 123 (5.69%)
    5 / 285 (1.75%)
    17 / 476 (3.57%)
    7 / 151 (4.64%)
    15 / 213 (7.04%)
    35 / 354 (9.89%)
         occurrences all number
    3
    1
    11
    1
    4
    1
    8
    7
    18
    7
    23
    47

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Dec 2011
    The overall reason of this amendment was to include clarification that the sponsor tracked all serious adverse events (SAEs) for 20 weeks following the last dose of study agent and correction of the time and events schedule to indicate that subjects should undergo a video ileocolonoscopy with biopsies for ribonucleic acid (RNA) analysis and histology at their early termination visit, as well as some minor editorial changes.
    24 Jun 2014
    The overall reason of this amendment was to include clarification of study-related procedures when subjects terminated participation in the study and to specify that subjects discontinuing study agent administration on or after Week 36 should complete the Week 44 visit in addition to a final safety visit.
    06 Aug 2015
    The overall reason of this amendment was to extend the long-term extension by 1 year to a total of 4 years after the Week 44 primary endpoint of this study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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