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    Clinical Trial Results:
    A Multicenter, Long-term Follow-up Study of the Safety and Efficacy of BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex in Patients with Idiopathic Overactive Bladder with Urinary Incontinence

    Summary
    EudraCT number
    		 2009-013089-26
    Trial protocol
    		 GB   BE   DE   CZ   PL  
    Global end of trial date
    05 Aug 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Sep 2016
    First version publication date
    18 Sep 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    191622-096
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00915525
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan Limited
    Sponsor organisation address
    Allergan Limited Marlow International The Parkway, Marlow, United Kingdom, SL7 1YL
    Public contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.com
    Scientific contact
    Allergan Limited EU Regulatory Dept, Allergan Limited, 44 1628 494444, ml-eu_reg_affairs@allergan.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
    05 Aug 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the long-term safety and efficacy of BOTOX in patients with idiopathic OAB with urinary incontinence whose symptoms had not been adequately managed with anticholinergic therapy.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form .
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Mar 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 48
    Country: Number of subjects enrolled
    Canada: 61
    Country: Number of subjects enrolled
    Czech Republic: 61
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    Poland: 57
    Country: Number of subjects enrolled
    Russian Federation: 65
    Country: Number of subjects enrolled
    United States: 483
    Country: Number of subjects enrolled
    Germany: 30
    Worldwide total number of subjects
    829
    EEA total number of subjects
    220
    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)
    485
    From 65 to 84 years
    334
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a long-term follow-up study that enrolled patients after participation in the preceding studies 191622-095 (NCT00910845) and 191622-520 (NCT00910520). A total of 829 patients received at least 1 BOTOX treatment in Study 191622-096 or in the preceding studies.

    Pre-assignment
    Screening details
    		 Following a planned interim analysis, the protocol was amended to remove the option to escalate to the 150U dose. The dose groups reflect the highest dose received (i.e. 100U BOTOX includes patients who only received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U at any time during the study).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 botulinum toxin Type A 100U
    Arm description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botulinum Toxin Type A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Arm title
    		 botulinum toxin Type A 150U
    Arm description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botulinum Toxin Type A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Number of subjects in period 1
    		botulinum toxin Type A 100U botulinum toxin Type A 150U
    Started
    543
    286
    Completed
    278
    151
    Not completed
    265
    135
         Retreat Request >Wk 144 (exclusionary)
    4
    5
         Patient Moved
    15
    9
         Other Reason
    35
    12
         Study Burden
    28
    12
         Missing
    12
    1
         Consent withdrawn by subject
    59
    21
         Non-Compliance
    3
    1
         Site Closed
    27
    9
         Adverse event, non-fatal
    29
    13
         Pregnancy
    2
    -
         Lost to follow-up
    27
    16
         Protocol deviation
    9
    4
         Lack of efficacy
    15
    32

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 829
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.1 ± 13.37 -
    Gender, Male/Female
    Units: Participants
        Female
    		 749 749
        Male
    		 80 80
    Subject analysis sets

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 6
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 6
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis sets values
    		 botulinum toxin Type A 100U Treatment Cycle 1 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects
    829
    608
    116
    388
    179
    273
    131
    185
    88
    139
    50
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    60.15 ± 13.37
    60.35 ± 13.03
    59.24 ± 14.5
    60.76 ± 13.17
    58 ± 14.18
    59.74 ± 13.64
    58.73 ± 13.03
    59.45 ± 12.28
    60.76 ± 12.24
    59.58 ± 11.13
    60.08 ± 12.83
    Gender, Male/Female
    Units: Participants
        Female
    749
    553
    101
    362
    164
    257
    123
    172
    83
    132
    49
        Male
    80
    55
    15
    26
    15
    16
    8
    13
    5
    7
    1

    End points

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    End points reporting groups
    Reporting group title
    botulinum toxin Type A 100U
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 3
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 5
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 100U Treatment Cycle 6
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 100 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Subject analysis set title
    botulinum toxin Type A 150U Treatment Cycle 6
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    all patients with data at the time point who received at least 1 BOTOX 150 U treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520)

    Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [1]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    829
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    5.55 ± 3.617
        Chg from Study BL at Wk 12 Tmt Cycle1 (N=812)
    -3.26 ± 3.439
    No statistical analyses for this end point

    Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [2]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 2
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    608
    116
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    5.7 ± 3.685
    5.66 ± 3.798
        Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108)
    -3.64 ± 3.402
    -3.05 ± 3.69
    No statistical analyses for this end point

    Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [3]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 3
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    388
    179
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    5.65 ± 3.38
    6.3 ± 4.28
        Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170)
    -3.82 ± 3.341
    -3.46 ± 3.771
    No statistical analyses for this end point

    Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [4]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 4
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    273
    131
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    5.78 ± 3.463
    6.19 ± 4.14
        Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122)
    -3.48 ± 3.733
    -3.32 ± 3.972
    No statistical analyses for this end point

    Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [5]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 5
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    185
    88
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    5.47 ± 3.283
    6.43 ± 3.622
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85)
    -3.34 ± 3.791
    -3.58 ± 3.266
    No statistical analyses for this end point

    Primary: Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Urinary Incontinence Episodes [6]
    End point description
    Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 6
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    139
    50
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    5.65 ± 3.238
    7.17 ± 4.223
        Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48)
    -3.05 ± 3.493
    -3.12 ± 3.753
    No statistical analyses for this end point

    Primary: Percentage of Patients with a Positive Response on the 4-Point Treatment Benefit Scale (TBS)

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    End point title
    		 Percentage of Patients with a Positive Response on the 4-Point Treatment Benefit Scale (TBS) [7]
    End point description
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
    End point type
    Primary
    End point timeframe
    Week 12 Treatment Cycle 1
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    812
    Units: Percentage of Patients
        number (not applicable)
    74
    No statistical analyses for this end point

    Primary: Percentage of Patients with a Positive Response on the 4-Point TBS

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    End point title
    		 Percentage of Patients with a Positive Response on the 4-Point TBS [8]
    End point description
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
    End point type
    Primary
    End point timeframe
    Week 12 Treatment Cycle 2
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    594
    110
    Units: Percentage of Patients
        number (not applicable)
    81.3
    71.8
    No statistical analyses for this end point

    Primary: Percentage of Patients with a Positive Response on the 4-Point TBS

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    End point title
    		 Percentage of Patients with a Positive Response on the 4-Point TBS [9]
    End point description
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
    End point type
    Primary
    End point timeframe
    Week 12 Treatment Cycle 3
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    374
    173
    Units: Percentage of Patients
        number (not applicable)
    82.1
    71.1
    No statistical analyses for this end point

    Primary: Percentage of Patients with a Positive Response on the 4-Point TBS

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    End point title
    		 Percentage of Patients with a Positive Response on the 4-Point TBS [10]
    End point description
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
    End point type
    Primary
    End point timeframe
    Week 12 Treatment Cycle 4
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    263
    123
    Units: Percentage of Patients
        number (not applicable)
    78.3
    81.3
    No statistical analyses for this end point

    Primary: Percentage of Patients with a Positive Response on the 4-Point TBS

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    End point title
    		 Percentage of Patients with a Positive Response on the 4-Point TBS [11]
    End point description
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
    End point type
    Primary
    End point timeframe
    Week 12 Treatment Cycle 5
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    179
    86
    Units: Percentage of Patients
        number (not applicable)
    83.2
    81.4
    No statistical analyses for this end point

    Primary: Percentage of Patients with a Positive Response on the 4-Point TBS

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    End point title
    		 Percentage of Patients with a Positive Response on the 4-Point TBS [12]
    End point description
    The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
    End point type
    Primary
    End point timeframe
    Week 12 Treatment Cycle 6
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis is reported for this outcome measure
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    136
    48
    Units: Percentage of Patients
        number (not applicable)
    80.9
    81.3
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Daily Average Number of Micturition Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Micturition Episodes
    End point description
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 1
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    829
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    11.7 ± 3.584
        Chg from Study BL at Wk 12 Tmt Cycle1 (N=812)
    -2.6 ± 2.887
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Daily Average Number of Micturition Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Micturition Episodes
    End point description
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 2
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    608
    116
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    11.83 ± 3.634
    11.48 ± 3.912
        Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108)
    -2.89 ± 3.037
    -2.31 ± 3.293
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Daily Average Number of Micturition Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Micturition Episodes
    End point description
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 3
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    388
    179
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    11.65 ± 3.553
    12.22 ± 3.76
        Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170)
    -2.86 ± 3.058
    -3.01 ± 3.217
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Daily Average Number of Micturition Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Micturition Episodes
    End point description
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 4
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    273
    131
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    11.68 ± 3.456
    11.82 ± 3.442
        Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122)
    -2.69 ± 3.485
    -2.78 ± 2.882
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Daily Average Number of Micturition Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Micturition Episodes
    End point description
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 5
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    185
    88
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    11.55 ± 3.261
    11.79 ± 2.77
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85)
    -2.85 ± 3.181
    -3.19 ± 2.772
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Daily Average Number of Micturition Episodes

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    End point title
    		 Change from Study Baseline in the Daily Average Number of Micturition Episodes
    End point description
    The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 6
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    139
    50
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    11.85 ± 3.377
    11.81 ± 2.99
        Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48)
    -2.76 ± 3.153
    -2.66 ± 3.351
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score

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    End point title
    		 Change from Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
    End point description
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 1
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    827
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    34.3 ± 18.58
        Chg from Study BL at Wk 12 Tmt Cycle1 (N=810)
    26 ± 24.84
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the I-QOL Questionnaire Total Summary Score

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    End point title
    		 Change from Study Baseline in the I-QOL Questionnaire Total Summary Score
    End point description
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 2
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    606
    116
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    33.8 ± 18.72
    32.8 ± 17.91
        Chg from Study BL at Wk 12 Tmt Cycle2 (N=586, 109)
    28.6 ± 24.38
    21.6 ± 23.71
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the I-QOL Questionnaire Total Summary Score

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    End point title
    		 Change from Study Baseline in the I-QOL Questionnaire Total Summary Score
    End point description
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 3
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    386
    179
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    33.8 ± 18.21
    31.9 ± 18.17
        Chg from Study BL at Wk 12 Tmt Cycle3 (N=371, 173)
    27.6 ± 22.39
    23.7 ± 25.68
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the I-QOL Questionnaire Total Summary Score

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    End point title
    		 Change from Study Baseline in the I-QOL Questionnaire Total Summary Score
    End point description
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 4
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    271
    131
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    31.4 ± 17.32
    32.5 ± 19.36
        Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 124)
    27.3 ± 24.9
    20.3 ± 22.63
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the I-QOL Questionnaire Total Summary Score

    		 Close Top of page
    End point title
    		 Change from Study Baseline in the I-QOL Questionnaire Total Summary Score
    End point description
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 5
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    184
    88
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    31.2 ± 17.49
    31.9 ± 20.3
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86)
    28.1 ± 23.75
    19.5 ± 21.43
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the I-QOL Questionnaire Total Summary Score

    		 Close Top of page
    End point title
    		 Change from Study Baseline in the I-QOL Questionnaire Total Summary Score
    End point description
    The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 6
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    138
    50
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    30.3 ± 17.87
    30.2 ± 20.28
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86)
    22.6 ± 24.99
    18.3 ± 14.91
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the King’s Health Questionnaire (KHQ) Role Limitations Domain

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    End point title
    		 Change from Study Baseline in the King’s Health Questionnaire (KHQ) Role Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 1
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    824
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    64.3 ± 28.77
        Chg from Study BL at Wk 12 Tmt Cycle1 (N=813)
    -28.5 ± 34.32
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Role Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Role Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 2
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    605
    115
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    64.5 ± 28.51
    66.2 ± 30.15
        Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109)
    -32.1 ± 34.29
    -29.2 ± 35.94
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Role Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Role Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 3
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    387
    177
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    64.7 ± 28.36
    63.4 ± 30.41
        Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171)
    -29.7 ± 33.47
    -27.9 ± 34.57
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Role Limitations Domain

    		 Close Top of page
    End point title
    		 Change from Study Baseline in the KHQ Role Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 4
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    272
    130
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    66.3 ± 27.65
    62.3 ± 31.17
        Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123)
    -30.9 ± 33.82
    -23.4 ± 33.05
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Role Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Role Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 5
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    185
    87
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    65.4 ± 29.15
    62.6 ± 31.84
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85)
    -30.8 ± 35.13
    -26.3 ± 28.45
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Role Limitations Domain

    		 Close Top of page
    End point title
    		 Change from Study Baseline in the KHQ Role Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 6
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    138
    50
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    66.4 ± 30
    60.3 ± 33.15
        Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48)
    -24.8 ± 38.93
    -22.9 ± 25.64
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Social Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Social Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 1
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    824
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    43.1 ± 30.79
        Chg from Study BL at Wk 12 Tmt Cycle1 (N=813)
    -18.4 ± 29.46
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Social Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Social Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 2
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    605
    115
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    43 ± 30.96
    48.4 ± 30.12
        Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109)
    -20 ± 29.12
    -19 ± 28.55
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Social Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Social Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 3
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    387
    177
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    42.8 ± 31.02
    45.4 ± 31.38
        Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171)
    -17.9 ± 29.26
    -19.2 ± 28.31
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Social Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Social Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 4
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    272
    130
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    44.7 ± 31.86
    43.2 ± 30.46
        Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123)
    -19.8 ± 31.26
    -16.1 ± 23.17
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Social Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Social Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 5
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    185
    87
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    44.4 ± 31.39
    43.4 ± 32.89
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85)
    -21.7 ± 28.47
    -15.7 ± 24.52
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in the KHQ Social Limitations Domain

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    End point title
    		 Change from Study Baseline in the KHQ Social Limitations Domain
    End point description
    The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 6
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    138
    50
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    46.7 ± 32.72
    43.3 ± 32.56
        Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48)
    -17 ± 33.59
    -17.6 ± 24.43
    No statistical analyses for this end point

    Secondary: Change From Study Baseline in Daily Frequency of Urgency Episodes

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    End point title
    		 Change From Study Baseline in Daily Frequency of Urgency Episodes
    End point description
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 1
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 1
    Number of subjects analysed
    829
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    8.55 ± 4.206
        Chg from Study BL at Wk 12 Tmt Cycle1 (N=812)
    -3.81 ± 4.031
    No statistical analyses for this end point

    Secondary: Change From Study Baseline in Daily Frequency of Urgency Episodes

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    End point title
    		 Change From Study Baseline in Daily Frequency of Urgency Episodes
    End point description
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 2
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2
    Number of subjects analysed
    608
    116
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    8.63 ± 4.188
    9.09 ± 4.764
        Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108)
    -4.07 ± 4.046
    -3.96 ± 4.519
    No statistical analyses for this end point

    Secondary: Change From Study Baseline in Daily Frequency of Urgency Episodes

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    End point title
    		 Change From Study Baseline in Daily Frequency of Urgency Episodes
    End point description
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 3
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3
    Number of subjects analysed
    388
    179
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    8.62 ± 4.055
    9.28 ± 4.552
        Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170)
    -4.22 ± 4.12
    -3.86 ± 4.332
    No statistical analyses for this end point

    Secondary: Change From Study Baseline in Daily Frequency of Urgency Episodes

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    End point title
    		 Change From Study Baseline in Daily Frequency of Urgency Episodes
    End point description
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 4
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4
    Number of subjects analysed
    273
    131
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    8.65 ± 3.951
    8.98 ± 4.241
        Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122)
    -3.92 ± 4.341
    -3.5 ± 3.916
    No statistical analyses for this end point

    Secondary: Change From Study Baseline in Daily Frequency of Urgency Episodes

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    End point title
    		 Change From Study Baseline in Daily Frequency of Urgency Episodes
    End point description
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 5
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5
    Number of subjects analysed
    185
    88
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    8.67 ± 3.961
    8.89 ± 3.341
        Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85)
    -4.11 ± 4.549
    -3.56 ± 3.576
    No statistical analyses for this end point

    Secondary: Change From Study Baseline in Daily Frequency of Urgency Episodes

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    End point title
    		 Change From Study Baseline in Daily Frequency of Urgency Episodes
    End point description
    The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 12 Treatment Cycle 6
    End point values
    		 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6
    Number of subjects analysed
    139
    50
    Units: Number of Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    8.98 ± 4.059
    8.84 ± 3.629
        Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48)
    -3.95 ± 4.662
    -2.64 ± 4.112
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were monitored from informed consent signature to the end of study for each subject.
    Adverse event reporting additional description
    BOTOX-Treated Population includes all patients who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520), and is used to assess adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs are reported by treatment cycle.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 1
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 2
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 2
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 3
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 3
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 4
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 4
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 5
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 5
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 6
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 6
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 7
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 7
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 8
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 8
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 9
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 9
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 10
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 150U Treatment Cycle 10
    Reporting group description
    		 Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 11
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 12
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Reporting group title
    botulinum toxin Type A 100U Treatment Cycle 13
    Reporting group description
    		 Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.

    Serious adverse events
    		 botulinum toxin Type A 100U Treatment Cycle 1 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6 botulinum toxin Type A 100U Treatment Cycle 7 botulinum toxin Type A 150U Treatment Cycle 7 botulinum toxin Type A 100U Treatment Cycle 8 botulinum toxin Type A 150U Treatment Cycle 8 botulinum toxin Type A 100U Treatment Cycle 9 botulinum toxin Type A 150U Treatment Cycle 9 botulinum toxin Type A 100U Treatment Cycle 10 botulinum toxin Type A 150U Treatment Cycle 10 botulinum toxin Type A 100U Treatment Cycle 11 botulinum toxin Type A 100U Treatment Cycle 12 botulinum toxin Type A 100U Treatment Cycle 13
    Total subjects affected by serious adverse events
         subjects affected / exposed
    71 / 829 (8.56%)
    62 / 608 (10.20%)
    7 / 116 (6.03%)
    32 / 388 (8.25%)
    13 / 179 (7.26%)
    18 / 273 (6.59%)
    8 / 131 (6.11%)
    15 / 185 (8.11%)
    4 / 88 (4.55%)
    8 / 139 (5.76%)
    3 / 50 (6.00%)
    3 / 93 (3.23%)
    0 / 27 (0.00%)
    4 / 69 (5.80%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    1 / 2 (50.00%)
    2 / 20 (10.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 829 (0.12%)
    5 / 608 (0.82%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer Stage II
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Carcinoma Cell Type Unspecified Stage III
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
    Additional description: MALE ONLY
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    2 / 139 (1.44%)
    1 / 50 (2.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Leiomyoma
    Additional description: FEMALE ONLY
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign Neoplasm of Spinal Cord
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid Adenoma
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyogenic Granuloma
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign Ovarian Tumour
    Additional description: FEMALE ONLY
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant Melanoma in Situ
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    B-Cell Small Lymphocytic Lymphoma
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Arterial Thrombosis
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial Occlusive Disease
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arterial Disorder
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Temporal Arteritis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose Vein
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Preventive Surgery
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fatigue
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hernia Obstructive
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Medical Device Complication
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device Ineffective
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Drug Hypersensitivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Allergy to Plants
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic Shock
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
    Additional description: MALE ONLY
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    1 / 88 (1.14%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polycystic Ovaries
    Additional description: FEMALE ONLY
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Haemorrhage
    Additional description: FEMALE ONLY
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal Prolapse
    Additional description: FEMALE ONLY
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical Polyp
    Additional description: FEMALE ONLY
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine Prolapse
    Additional description: FEMALE ONLY
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal Haemorrhage
    Additional description: FEMALE ONLY
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perineal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometrial Hypertrophy
    Additional description: FEMALE ONLY
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    1 / 88 (1.14%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary Embolism
         subjects affected / exposed
    3 / 829 (0.36%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    2 / 185 (1.08%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal obstruction
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Major Depression
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression Suicidal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional State
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Sigmoidoscopy
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart Rate Increased
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Comminuted Fracture
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    0 / 829 (0.00%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental Overdose
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional Hernia
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound Dehiscence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radiation Injury
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    1 / 2 (50.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    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
    Foramen Magnum Stenosis
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital Diaphragmatic Hernia
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular Tachycardia
         subjects affected / exposed
    2 / 829 (0.24%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    1 / 829 (0.12%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Palpitations
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress Cardiomyopathy
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral Valve Prolapse
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Bulbar Palsy
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Disorder
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obturator Neuropathy
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restless Legs Syndrome
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral Artery Thrombosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical Radiculopathy
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peroneal Nerve Palsy
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous Floaters
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    2 / 131 (1.53%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Pain Lower
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn’s Disease
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 829 (0.00%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    1 / 50 (2.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal Hernia
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    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
    Dermatitis Atopic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Swelling Face
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Actinic keratosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Excessive skin
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin Wrinkling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    1 / 2 (50.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Failure Acute
         subjects affected / exposed
    2 / 829 (0.24%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus Ureteric
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urge Incontinence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    1 / 88 (1.14%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis Interstitial
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydroureter
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvi-Ureteric Obstruction
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    7 / 829 (0.84%)
    8 / 608 (1.32%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    1 / 88 (1.14%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    2 / 185 (1.08%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    2 / 829 (0.24%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot Deformity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle Spasms
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in Extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 829 (0.00%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    1 / 179 (0.56%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Osteoarthritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    2 / 273 (0.73%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon Disorder
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    3 / 829 (0.36%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    3 / 388 (0.77%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    2 / 185 (1.08%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    1 / 50 (2.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 829 (0.24%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 829 (0.24%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal Abscess
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 829 (0.00%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    2 / 179 (1.12%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    1 / 50 (2.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 botulinum toxin Type A 100U Treatment Cycle 1 botulinum toxin Type A 100U Treatment Cycle 2 botulinum toxin Type A 150U Treatment Cycle 2 botulinum toxin Type A 100U Treatment Cycle 3 botulinum toxin Type A 150U Treatment Cycle 3 botulinum toxin Type A 100U Treatment Cycle 4 botulinum toxin Type A 150U Treatment Cycle 4 botulinum toxin Type A 100U Treatment Cycle 5 botulinum toxin Type A 150U Treatment Cycle 5 botulinum toxin Type A 100U Treatment Cycle 6 botulinum toxin Type A 150U Treatment Cycle 6 botulinum toxin Type A 100U Treatment Cycle 7 botulinum toxin Type A 150U Treatment Cycle 7 botulinum toxin Type A 100U Treatment Cycle 8 botulinum toxin Type A 150U Treatment Cycle 8 botulinum toxin Type A 100U Treatment Cycle 9 botulinum toxin Type A 150U Treatment Cycle 9 botulinum toxin Type A 100U Treatment Cycle 10 botulinum toxin Type A 150U Treatment Cycle 10 botulinum toxin Type A 100U Treatment Cycle 11 botulinum toxin Type A 100U Treatment Cycle 12 botulinum toxin Type A 100U Treatment Cycle 13
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    297 / 829 (35.83%)
    204 / 608 (33.55%)
    28 / 116 (24.14%)
    135 / 388 (34.79%)
    50 / 179 (27.93%)
    86 / 273 (31.50%)
    34 / 131 (25.95%)
    53 / 185 (28.65%)
    35 / 88 (39.77%)
    43 / 139 (30.94%)
    10 / 50 (20.00%)
    37 / 93 (39.78%)
    16 / 27 (59.26%)
    21 / 69 (30.43%)
    9 / 11 (81.82%)
    18 / 48 (37.50%)
    6 / 7 (85.71%)
    14 / 37 (37.84%)
    1 / 2 (50.00%)
    12 / 20 (60.00%)
    1 / 5 (20.00%)
    2 / 2 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign Neoplasm of Skin
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Capsular Contracture Associated with Breast Implant
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    8 / 829 (0.97%)
    7 / 608 (1.15%)
    0 / 116 (0.00%)
    3 / 388 (0.77%)
    3 / 179 (1.68%)
    1 / 273 (0.37%)
    2 / 131 (1.53%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    3 / 93 (3.23%)
    1 / 27 (3.70%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    10
    7
    0
    3
    3
    1
    2
    1
    0
    0
    0
    3
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    16 / 829 (1.93%)
    20 / 608 (3.29%)
    1 / 116 (0.86%)
    6 / 388 (1.55%)
    2 / 179 (1.12%)
    1 / 273 (0.37%)
    1 / 131 (0.76%)
    3 / 185 (1.62%)
    0 / 88 (0.00%)
    2 / 139 (1.44%)
    2 / 50 (4.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    4 / 69 (5.80%)
    0 / 11 (0.00%)
    2 / 48 (4.17%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    18
    21
    1
    6
    2
    1
    1
    3
    0
    2
    2
    0
    0
    4
    0
    2
    0
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    5 / 829 (0.60%)
    7 / 608 (1.15%)
    0 / 116 (0.00%)
    3 / 388 (0.77%)
    1 / 179 (0.56%)
    2 / 273 (0.73%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    7
    8
    0
    3
    1
    2
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    2 / 37 (5.41%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    14 / 829 (1.69%)
    9 / 608 (1.48%)
    1 / 116 (0.86%)
    7 / 388 (1.80%)
    4 / 179 (2.23%)
    3 / 273 (1.10%)
    2 / 131 (1.53%)
    2 / 185 (1.08%)
    5 / 88 (5.68%)
    2 / 139 (1.44%)
    0 / 50 (0.00%)
    2 / 93 (2.15%)
    1 / 27 (3.70%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    22
    9
    1
    7
    5
    3
    2
    2
    5
    2
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Psychotic Disorder
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Investigations
    Residual Urine Volume
         subjects affected / exposed
    26 / 829 (3.14%)
    12 / 608 (1.97%)
    0 / 116 (0.00%)
    10 / 388 (2.58%)
    2 / 179 (1.12%)
    4 / 273 (1.47%)
    2 / 131 (1.53%)
    2 / 185 (1.08%)
    1 / 88 (1.14%)
    2 / 139 (1.44%)
    0 / 50 (0.00%)
    2 / 93 (2.15%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    31
    13
    0
    11
    3
    4
    2
    5
    1
    2
    0
    1
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    12 / 829 (1.45%)
    6 / 608 (0.99%)
    4 / 116 (3.45%)
    12 / 388 (3.09%)
    2 / 179 (1.12%)
    2 / 273 (0.73%)
    1 / 131 (0.76%)
    3 / 185 (1.62%)
    2 / 88 (2.27%)
    3 / 139 (2.16%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    2 / 27 (7.41%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    2 / 48 (4.17%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    15
    8
    4
    12
    2
    2
    1
    3
    2
    5
    0
    1
    2
    1
    0
    2
    0
    1
    0
    1
    0
    0
    Limb Injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    4
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Femur Fracture
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Muscle Strain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 829 (0.48%)
    2 / 608 (0.33%)
    1 / 116 (0.86%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    2 / 273 (0.73%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    1 / 88 (1.14%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    1 / 48 (2.08%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    2
    1
    1
    0
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Hand Fracture
         subjects affected / exposed
    1 / 829 (0.12%)
    2 / 608 (0.33%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 829 (0.97%)
    5 / 608 (0.82%)
    0 / 116 (0.00%)
    4 / 388 (1.03%)
    0 / 179 (0.00%)
    2 / 273 (0.73%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    1 / 88 (1.14%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    8
    5
    0
    4
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Trigeminal Neuralgia
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 829 (0.36%)
    4 / 608 (0.66%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    2 / 273 (0.73%)
    2 / 131 (1.53%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    2 / 139 (1.44%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    4
    0
    2
    0
    2
    2
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    Leukocytosis
         subjects affected / exposed
    3 / 829 (0.36%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    3
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 829 (0.12%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    8 / 829 (0.97%)
    8 / 608 (1.32%)
    0 / 116 (0.00%)
    7 / 388 (1.80%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    1 / 27 (3.70%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    11
    11
    0
    11
    0
    2
    0
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    2
    0
    2
    0
    0
    Eye Inflammation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    23 / 829 (2.77%)
    20 / 608 (3.29%)
    2 / 116 (1.72%)
    5 / 388 (1.29%)
    4 / 179 (2.23%)
    6 / 273 (2.20%)
    4 / 131 (3.05%)
    4 / 185 (2.16%)
    2 / 88 (2.27%)
    2 / 139 (1.44%)
    2 / 50 (4.00%)
    1 / 93 (1.08%)
    3 / 27 (11.11%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    1 / 48 (2.08%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    27
    20
    2
    6
    4
    6
    5
    4
    2
    2
    2
    1
    3
    0
    0
    1
    1
    0
    0
    1
    0
    0
    Vomiting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    8 / 829 (0.97%)
    8 / 608 (1.32%)
    2 / 116 (1.72%)
    1 / 388 (0.26%)
    1 / 179 (0.56%)
    2 / 273 (0.73%)
    2 / 131 (1.53%)
    1 / 185 (0.54%)
    2 / 88 (2.27%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    2 / 27 (7.41%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    9
    8
    2
    1
    2
    2
    2
    1
    2
    1
    0
    1
    2
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 829 (1.57%)
    14 / 608 (2.30%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    2 / 179 (1.12%)
    3 / 273 (1.10%)
    2 / 131 (1.53%)
    2 / 185 (1.08%)
    1 / 88 (1.14%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    1 / 11 (9.09%)
    1 / 48 (2.08%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    14
    15
    0
    2
    4
    3
    2
    3
    1
    1
    0
    1
    0
    1
    1
    1
    0
    0
    0
    1
    0
    0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperkeratosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    1 / 27 (3.70%)
    1 / 69 (1.45%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Swelling Face
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Skin Wrinkling
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    1 / 2 (50.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 829 (0.48%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Dysuria
    alternative assessment type: Non-systematic
         subjects affected / exposed
    71 / 829 (8.56%)
    47 / 608 (7.73%)
    7 / 116 (6.03%)
    20 / 388 (5.15%)
    16 / 179 (8.94%)
    15 / 273 (5.49%)
    8 / 131 (6.11%)
    7 / 185 (3.78%)
    9 / 88 (10.23%)
    9 / 139 (6.47%)
    3 / 50 (6.00%)
    6 / 93 (6.45%)
    5 / 27 (18.52%)
    1 / 69 (1.45%)
    2 / 11 (18.18%)
    3 / 48 (6.25%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    89
    58
    7
    20
    19
    17
    9
    10
    9
    11
    3
    7
    5
    1
    2
    4
    0
    1
    0
    0
    0
    1
    Cystitis Glandularis
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Pollakiuria
         subjects affected / exposed
    10 / 829 (1.21%)
    13 / 608 (2.14%)
    3 / 116 (2.59%)
    6 / 388 (1.55%)
    4 / 179 (2.23%)
    1 / 273 (0.37%)
    2 / 131 (1.53%)
    1 / 185 (0.54%)
    1 / 88 (1.14%)
    2 / 139 (1.44%)
    2 / 50 (4.00%)
    2 / 93 (2.15%)
    1 / 27 (3.70%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    1 / 48 (2.08%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    14
    17
    5
    6
    4
    1
    3
    1
    1
    2
    2
    2
    1
    0
    0
    1
    1
    0
    0
    1
    0
    0
    Urinary Retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    34 / 829 (4.10%)
    23 / 608 (3.78%)
    0 / 116 (0.00%)
    11 / 388 (2.84%)
    4 / 179 (2.23%)
    7 / 273 (2.56%)
    2 / 131 (1.53%)
    3 / 185 (1.62%)
    3 / 88 (3.41%)
    3 / 139 (2.16%)
    0 / 50 (0.00%)
    2 / 93 (2.15%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    1 / 48 (2.08%)
    1 / 7 (14.29%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    40
    26
    0
    11
    4
    8
    2
    3
    3
    3
    0
    2
    0
    0
    0
    1
    1
    1
    0
    1
    0
    0
    Haematuria
         subjects affected / exposed
    25 / 829 (3.02%)
    12 / 608 (1.97%)
    2 / 116 (1.72%)
    8 / 388 (2.06%)
    2 / 179 (1.12%)
    2 / 273 (0.73%)
    2 / 131 (1.53%)
    3 / 185 (1.62%)
    2 / 88 (2.27%)
    4 / 139 (2.88%)
    0 / 50 (0.00%)
    4 / 93 (4.30%)
    1 / 27 (3.70%)
    2 / 69 (2.90%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    2 / 37 (5.41%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    29
    12
    2
    8
    2
    2
    2
    3
    3
    4
    0
    4
    1
    2
    0
    0
    0
    2
    0
    0
    0
    0
    Urinary Incontinence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 829 (0.48%)
    4 / 608 (0.66%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    1 / 179 (0.56%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    1 / 2 (50.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    5
    0
    1
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Bladder Hypertrophy
         subjects affected / exposed
    1 / 829 (0.12%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urine Abnormality
         subjects affected / exposed
    2 / 829 (0.24%)
    2 / 608 (0.33%)
    1 / 116 (0.86%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Musculoskeletal and connective tissue disorders
    Back Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    27 / 829 (3.26%)
    26 / 608 (4.28%)
    1 / 116 (0.86%)
    8 / 388 (2.06%)
    3 / 179 (1.68%)
    6 / 273 (2.20%)
    4 / 131 (3.05%)
    3 / 185 (1.62%)
    2 / 88 (2.27%)
    2 / 139 (1.44%)
    1 / 50 (2.00%)
    1 / 93 (1.08%)
    2 / 27 (7.41%)
    5 / 69 (7.25%)
    1 / 11 (9.09%)
    2 / 48 (4.17%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    2 / 20 (10.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    32
    28
    1
    8
    4
    6
    4
    3
    2
    2
    1
    1
    2
    6
    1
    2
    0
    1
    0
    3
    0
    0
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    16 / 829 (1.93%)
    21 / 608 (3.45%)
    1 / 116 (0.86%)
    9 / 388 (2.32%)
    6 / 179 (3.35%)
    4 / 273 (1.47%)
    3 / 131 (2.29%)
    2 / 185 (1.08%)
    0 / 88 (0.00%)
    3 / 139 (2.16%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    26
    23
    1
    10
    6
    4
    3
    2
    0
    3
    0
    1
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    Pain in Extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 829 (1.57%)
    16 / 608 (2.63%)
    1 / 116 (0.86%)
    6 / 388 (1.55%)
    0 / 179 (0.00%)
    3 / 273 (1.10%)
    0 / 131 (0.00%)
    2 / 185 (1.08%)
    1 / 88 (1.14%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    1 / 27 (3.70%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    15
    20
    1
    7
    0
    3
    0
    2
    1
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 829 (0.36%)
    9 / 608 (1.48%)
    0 / 116 (0.00%)
    3 / 388 (0.77%)
    1 / 179 (0.56%)
    2 / 273 (0.73%)
    0 / 131 (0.00%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    1 / 50 (2.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    2 / 37 (5.41%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    4
    9
    0
    4
    1
    2
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    Tendonitis
         subjects affected / exposed
    6 / 829 (0.72%)
    3 / 608 (0.49%)
    0 / 116 (0.00%)
    1 / 388 (0.26%)
    2 / 179 (1.12%)
    1 / 273 (0.37%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    1 / 88 (1.14%)
    1 / 139 (0.72%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    1 / 2 (50.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    9
    0
    4
    0
    1
    2
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Cervical Spinal Stenosis
         subjects affected / exposed
    0 / 829 (0.00%)
    0 / 608 (0.00%)
    0 / 116 (0.00%)
    0 / 388 (0.00%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    225 / 829 (27.14%)
    161 / 608 (26.48%)
    17 / 116 (14.66%)
    107 / 388 (27.58%)
    39 / 179 (21.79%)
    67 / 273 (24.54%)
    28 / 131 (21.37%)
    40 / 185 (21.62%)
    20 / 88 (22.73%)
    28 / 139 (20.14%)
    6 / 50 (12.00%)
    24 / 93 (25.81%)
    4 / 27 (14.81%)
    9 / 69 (13.04%)
    3 / 11 (27.27%)
    13 / 48 (27.08%)
    2 / 7 (28.57%)
    9 / 37 (24.32%)
    1 / 2 (50.00%)
    4 / 20 (20.00%)
    0 / 5 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    400
    286
    28
    159
    57
    90
    39
    50
    26
    32
    11
    26
    5
    11
    3
    14
    3
    10
    1
    5
    0
    1
    Bacteriuria
         subjects affected / exposed
    70 / 829 (8.44%)
    54 / 608 (8.88%)
    8 / 116 (6.90%)
    32 / 388 (8.25%)
    5 / 179 (2.79%)
    21 / 273 (7.69%)
    5 / 131 (3.82%)
    11 / 185 (5.95%)
    7 / 88 (7.95%)
    10 / 139 (7.19%)
    2 / 50 (4.00%)
    8 / 93 (8.60%)
    2 / 27 (7.41%)
    4 / 69 (5.80%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    1 / 2 (50.00%)
    2 / 20 (10.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    99
    78
    12
    34
    5
    25
    6
    12
    7
    10
    2
    9
    2
    6
    0
    0
    0
    0
    1
    2
    0
    0
    Sinusitis
         subjects affected / exposed
    26 / 829 (3.14%)
    19 / 608 (3.13%)
    2 / 116 (1.72%)
    11 / 388 (2.84%)
    4 / 179 (2.23%)
    5 / 273 (1.83%)
    0 / 131 (0.00%)
    4 / 185 (2.16%)
    0 / 88 (0.00%)
    3 / 139 (2.16%)
    0 / 50 (0.00%)
    2 / 93 (2.15%)
    2 / 27 (7.41%)
    2 / 69 (2.90%)
    0 / 11 (0.00%)
    3 / 48 (6.25%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    27
    19
    2
    11
    4
    6
    0
    4
    0
    3
    0
    2
    2
    2
    0
    3
    1
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    30 / 829 (3.62%)
    17 / 608 (2.80%)
    5 / 116 (4.31%)
    7 / 388 (1.80%)
    5 / 179 (2.79%)
    5 / 273 (1.83%)
    5 / 131 (3.82%)
    6 / 185 (3.24%)
    2 / 88 (2.27%)
    2 / 139 (1.44%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    2 / 11 (18.18%)
    1 / 48 (2.08%)
    0 / 7 (0.00%)
    1 / 37 (2.70%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    37
    17
    5
    7
    5
    5
    5
    6
    2
    4
    0
    0
    0
    1
    2
    1
    0
    1
    0
    0
    0
    0
    Upper Respiratory Tract Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    13 / 829 (1.57%)
    23 / 608 (3.78%)
    5 / 116 (4.31%)
    13 / 388 (3.35%)
    4 / 179 (2.23%)
    2 / 273 (0.73%)
    1 / 131 (0.76%)
    7 / 185 (3.78%)
    3 / 88 (3.41%)
    2 / 139 (1.44%)
    2 / 50 (4.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    1 / 11 (9.09%)
    4 / 48 (8.33%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    14
    23
    7
    13
    4
    2
    1
    8
    4
    2
    2
    2
    0
    1
    2
    4
    1
    0
    0
    0
    0
    0
    Acute Sinusitis
         subjects affected / exposed
    0 / 829 (0.00%)
    1 / 608 (0.16%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    2 / 139 (1.44%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    1 / 11 (9.09%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Bronchitis
         subjects affected / exposed
    24 / 829 (2.90%)
    14 / 608 (2.30%)
    2 / 116 (1.72%)
    11 / 388 (2.84%)
    1 / 179 (0.56%)
    7 / 273 (2.56%)
    1 / 131 (0.76%)
    4 / 185 (2.16%)
    2 / 88 (2.27%)
    4 / 139 (2.88%)
    2 / 50 (4.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    2 / 69 (2.90%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    24
    15
    2
    12
    1
    7
    1
    5
    2
    4
    2
    0
    0
    2
    0
    0
    1
    0
    0
    1
    0
    0
    Respiratory Tract Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 829 (0.24%)
    2 / 608 (0.33%)
    0 / 116 (0.00%)
    2 / 388 (0.52%)
    0 / 179 (0.00%)
    1 / 273 (0.37%)
    1 / 131 (0.76%)
    1 / 185 (0.54%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    1 / 7 (14.29%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    2
    0
    2
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Lower Respiratory Tract Infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 829 (0.36%)
    4 / 608 (0.66%)
    1 / 116 (0.86%)
    1 / 388 (0.26%)
    0 / 179 (0.00%)
    0 / 273 (0.00%)
    0 / 131 (0.00%)
    2 / 185 (1.08%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    1 / 93 (1.08%)
    0 / 27 (0.00%)
    1 / 69 (1.45%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    1 / 20 (5.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    3
    6
    1
    1
    0
    0
    0
    2
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Pneumonia
         subjects affected / exposed
    5 / 829 (0.60%)
    4 / 608 (0.66%)
    0 / 116 (0.00%)
    6 / 388 (1.55%)
    1 / 179 (0.56%)
    3 / 273 (1.10%)
    0 / 131 (0.00%)
    2 / 185 (1.08%)
    0 / 88 (0.00%)
    1 / 139 (0.72%)
    2 / 50 (4.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    0 / 37 (0.00%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    1 / 5 (20.00%)
    0 / 2 (0.00%)
         occurrences all number
    6
    5
    0
    7
    1
    3
    0
    4
    0
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    3 / 829 (0.36%)
    2 / 608 (0.33%)
    1 / 116 (0.86%)
    1 / 388 (0.26%)
    1 / 179 (0.56%)
    0 / 273 (0.00%)
    1 / 131 (0.76%)
    0 / 185 (0.00%)
    0 / 88 (0.00%)
    0 / 139 (0.00%)
    0 / 50 (0.00%)
    0 / 93 (0.00%)
    0 / 27 (0.00%)
    0 / 69 (0.00%)
    0 / 11 (0.00%)
    0 / 48 (0.00%)
    0 / 7 (0.00%)
    2 / 37 (5.41%)
    0 / 2 (0.00%)
    0 / 20 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    5
    2
    1
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2010
    1.) The exclusion criterion relating to allergy or sensitivity to any component of the study medication was modified in accordance with the updated Investigator’s Brochure. 2) Urine dipstick reagent strip criteria were amended for a patient to be eligible for treatment in the study (patients only needed to be negative for nitrites and leukocyte esterase).
    01 Mar 2011
    1) The imputation of missing values for health outcomes questionnaires was removed. 2) The adverse event defined as “residual urine” was renamed “residual urine volume” per MedDRA version 13.1. 3) Additional text was added regarding follow-up diagnostic measures to be performed should there be unclear new findings suggestive of stones or other clinically relevant findings on bladder/kidney ultrasound. 4) It was clarified that patients diagnosed with new or recurrent malignancies, except basal cell carcinoma, should have been discontinued from the study. 5) All references to the intent-to-treat, safety, and per-protocol populations were replaced with the BOTOX-treated population.
    01 Dec 2011
    1) The duration of the study was extended from 2 years to 3 years. 2) The imputation method was removed for the primary efficacy variables.
    01 Aug 2012
    1) The option to escalate to a dose of 150 U BOTOX was removed. 2) An abortion (spontaneous or nonspontaneous) as a serious adverse event was added. 3) It was clarified that the focus of the analysis will be the repeat treatment data from the 100 U BOTOX group, and data from patients who received 150 U BOTOX are exploratory.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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