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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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    Close Top of page
    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

    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 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

    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 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

    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 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

    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 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

    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 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