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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 Urinary Incontinence Due to Neurogenic Detrusor Overactivity

    Summary
    EudraCT number
    2009-009216-53
    Trial protocol
    PT   NL   GB   FR   DE   IT   ES   BE   AT   CZ   SK  
    Global end of trial date
    04 Sep 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    191622-094
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00876447
    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
    14 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Sep 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety and maintenance of efficacy of BOTOX injected into the detrusor for the treatment of urinary incontinence caused by neurogenic detrusor overactivity in patients 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
    04 Apr 2009
    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
    United States: 209
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    Australia: 16
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Belgium: 16
    Country: Number of subjects enrolled
    Brazil: 15
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    Czech Republic: 15
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Netherlands Antilles: 9
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Portugal: 12
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    South Africa: 3
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    Slovakia: 6
    Country: Number of subjects enrolled
    Russian Federation: 8
    Country: Number of subjects enrolled
    Ukraine: 12
    Worldwide total number of subjects
    388
    EEA total number of subjects
    90
    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)
    363
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    This was a long-term follow-up study that enrolled patients after participation in Study 191622-515 or 191622-516. A total of 397 patients were enrolled and 388 patients received at least 1 BOTOX treatment in study 191622-094 or in the preceding studies.

    Pre-assignment
    Screening details
    The protocol was amended to remove the 300 U dose. Patients ongoing in the study who were treated with 300 U BOTOX prior to the amendment were assigned to 200 U BOTOX for all subsequent treatments. Participant Flow and Baseline Characteristics are based on the first BOTOX dose that patients received.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Monitor, Carer, Data analyst, Subject, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Botulinum Toxin Type A 300U
    Arm description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
    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 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Arm title
    Botulinum Toxin Type A 200U
    Arm description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
    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 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Number of subjects in period 1
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Started
    185
    203
    Completed
    105
    122
    Not completed
    80
    81
         Personal reasons
    30
    28
         Adverse event, non-fatal
    4
    8
         Pregnancy
    4
    2
         Other miscellaneous reasons
    3
    8
         Lost to follow-up
    6
    15
         Site closure
    19
    14
         Protocol deviation
    9
    3
         Lack of efficacy
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Botulinum Toxin Type A 300U
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U Total
    Number of subjects
    185 203 388
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    171 192 363
        From 65-84 years
    14 11 25
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    46.3 ± 12.96 46.5 ± 12.33 -
    Gender, Male/Female
    Units: Participants
        Female
    116 118 234
        Male
    69 85 154

    End points

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    End points reporting groups
    Reporting group title
    Botulinum Toxin Type A 300U
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 6 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 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    183
    201
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline (BL)
    4.4 ± 2.54
    4.5 ± 2.64
        Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195)
    -3.4 ± 3.16
    -3.2 ± 2.69
    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 [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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 6 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 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    161
    186
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    4.5 ± 2.62
    4.6 ± 2.71
        Chg from Study BL at Wk 6 Tmt Cycle2 (N=153, 175)
    -3.5 ± 3.13
    -3.3 ± 2.85
    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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 6 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 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    118
    173
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    4.4 ± 2.33
    4.6 ± 2.65
        Chg from Study BL at Wk 6 Tmt Cycle3 (N=109, 164)
    -3.3 ± 2.39
    -3.5 ± 2.96
    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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 6 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 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    67
    149
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    4.4 ± 2.13
    4.4 ± 2.57
        Chg from Study BL at Wk 6 Tmt Cycle4 (N=62, 141)
    -3.4 ± 2.57
    -3.5 ± 2.61
    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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
    End point type
    Primary
    End point timeframe
    Study Baseline, Week 6 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 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    33
    108
    Units: Incontinence Episodes
    arithmetic mean (standard deviation)
        Study Baseline
    4.1 ± 2.34
    4.6 ± 2.57
        Chg from Study BL at Wk 6 Tmt Cycle5 (N=29, 99)
    -3.7 ± 2.82
    -3.6 ± 2.27
    No statistical analyses for this end point

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

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    End point title
    Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 1
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    185
    202
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    33.9 ± 18.19
    34.4 ± 18.18
        Chg from Study BL at Wk 6 Tmt Cycle1 (N=180, 199)
    32.3 ± 26.07
    30.3 ± 26.37
    No statistical analyses for this end point

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

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    End point title
    Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 2
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    162
    185
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    33.3 ± 18.17
    33.8 ± 18.17
        Chg from Study BL at Wk 6 Tmt Cycle2 (N=157, 178)
    31.4 ± 27.73
    33.5 ± 26.23
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 3
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    118
    173
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    32.5 ± 17.83
    34.8 ± 18.95
        Chg from Study BL at Wk 6 Tmt Cycle3 (N=114, 164)
    28.8 ± 28.96
    30.4 ± 29.25
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 4
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    66
    151
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    27.9 ± 16.66
    35.5 ± 17.7
        Chg from Study BL at Wk 6 Tmt Cycle4 (N=63, 147)
    30.4 ± 31.77
    30.1 ± 26.07
    No statistical analyses for this end point

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

    Close Top of page
    End point title
    Change from Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 5
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    31
    109
    Units: Scores on a Scale
    arithmetic mean (standard deviation)
        Study Baseline
    32 ± 16.13
    33 ± 19.61
        Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 100)
    36.6 ± 28.28
    27.1 ± 24.54
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in Volume Per Void

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    End point title
    Change from Study Baseline in Volume Per Void
    End point description
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 1
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    178
    196
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Study Baseline
    147.3 ± 90.15
    154.2 ± 96.54
        Chg from Study BL at Wk 6 Tmt Cycle1 (N=168, 186)
    133.8 ± 137.23
    133.2 ± 128.19
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in Volume Per Void

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    End point title
    Change from Study Baseline in Volume Per Void
    End point description
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 2
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    157
    181
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Study Baseline
    149.8 ± 91.03
    151.9 ± 95.22
        Chg from Study BL at Wk 6 Tmt Cycle2 (N=146, 168)
    148 ± 134.45
    135.1 ± 127.62
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in Volume Per Void

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    End point title
    Change from Study Baseline in Volume Per Void
    End point description
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 3
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    114
    168
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Study Baseline
    155 ± 90.7
    149.6 ± 91.12
        Chg from Study BL at Wk 6 Tmt Cycle3 (N=105, 158)
    166.9 ± 133.59
    157.5 ± 129.81
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in Volume Per Void

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    End point title
    Change from Study Baseline in Volume Per Void
    End point description
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 4
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    65
    143
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Study Baseline
    159.7 ± 89.37
    151.7 ± 93.65
        Chg from Study BL at Wk 6 Tmt Cycle4 (N=61, 135)
    170.8 ± 128.26
    147.3 ± 122.09
    No statistical analyses for this end point

    Secondary: Change from Study Baseline in Volume Per Void

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    End point title
    Change from Study Baseline in Volume Per Void
    End point description
    The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
    End point type
    Secondary
    End point timeframe
    Study Baseline, Week 6 Treatment Cycle 5
    End point values
    Botulinum Toxin Type A 300U Botulinum Toxin Type A 200U
    Number of subjects analysed
    32
    104
    Units: Milliliters (mL)
    arithmetic mean (standard deviation)
        Study Baseline
    182.7 ± 85.03
    140.8 ± 91.32
        Chg from Study BL at Wk 6 Tmt Cycle5 (N=28, 95)
    163.5 ± 106.44
    160.2 ± 119.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from signing the informed consent to the end of study (Week 156).
    Adverse event reporting additional description
    The Botox-Treated Population includes all patients who received at least 1 BOTOX treatment (in Study 191622-094, 191622-515 or 191622-516) 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
    16.0
    Reporting groups
    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 1
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 1
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 2
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 2
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 3
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 3
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 4
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 4
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 5
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 5
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 6
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 6
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 300U Treatment Cycle 7
    Reporting group description
    Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 7
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 8
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 9
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 10
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 11
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Reporting group title
    Botulinum Toxin Type A 200U Treatment Cycle 12
    Reporting group description
    Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.

    Serious adverse events
    Botulinum Toxin Type A 300U Treatment Cycle 1 Botulinum Toxin Type A 200U Treatment Cycle 1 Botulinum Toxin Type A 300U Treatment Cycle 2 Botulinum Toxin Type A 200U Treatment Cycle 2 Botulinum Toxin Type A 300U Treatment Cycle 3 Botulinum Toxin Type A 200U Treatment Cycle 3 Botulinum Toxin Type A 300U Treatment Cycle 4 Botulinum Toxin Type A 200U Treatment Cycle 4 Botulinum Toxin Type A 300U Treatment Cycle 5 Botulinum Toxin Type A 200U Treatment Cycle 5 Botulinum Toxin Type A 300U Treatment Cycle 6 Botulinum Toxin Type A 200U Treatment Cycle 6 Botulinum Toxin Type A 300U Treatment Cycle 7 Botulinum Toxin Type A 200U Treatment Cycle 7 Botulinum Toxin Type A 200U Treatment Cycle 8 Botulinum Toxin Type A 200U Treatment Cycle 9 Botulinum Toxin Type A 200U Treatment Cycle 10 Botulinum Toxin Type A 200U Treatment Cycle 11 Botulinum Toxin Type A 200U Treatment Cycle 12
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 185 (15.14%)
    35 / 203 (17.24%)
    26 / 163 (15.95%)
    21 / 187 (11.23%)
    20 / 119 (16.81%)
    19 / 175 (10.86%)
    11 / 69 (15.94%)
    20 / 153 (13.07%)
    5 / 34 (14.71%)
    11 / 110 (10.00%)
    0 / 16 (0.00%)
    9 / 70 (12.86%)
    0 / 8 (0.00%)
    6 / 48 (12.50%)
    0 / 36 (0.00%)
    2 / 22 (9.09%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    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
         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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    2 / 34 (5.88%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
    Additional description: Males Only
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 185 (0.00%)
    2 / 203 (0.99%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 Neoplasm
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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: Females Only
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    1 / 48 (2.08%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Hypertension
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    2 / 175 (1.14%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 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
    Peripheral Vascular Disorder
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Abortion Induced
    Additional description: Females Only
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse Drug Reaction
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 185 (0.00%)
    2 / 203 (0.99%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    1 / 70 (1.43%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    1 / 11 (9.09%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 Dislocation
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema Peripheral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device Deployment Issue
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Impaired Healing
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 Malfunction
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Anaphylactic Reaction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Epididymitis
    Additional description: Males Only
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    1 / 69 (1.45%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic Prolapse
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erectile Dysfunction
    Additional description: Males Only
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    1 / 69 (1.45%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 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
    Pneumonia Aspiration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Mental Status Changes
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    1 / 70 (1.43%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute Psychosis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 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
    Confusional State
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Urine Cytology Abnormal
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 observation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    1 / 70 (1.43%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral Injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon Rupture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional Hernia
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 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
    Overdose
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    1 / 69 (1.45%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint Dislocation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scar
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    1 / 69 (1.45%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal Haematoma
    Additional description: Males Only
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    1 / 69 (1.45%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    1 / 48 (2.08%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    1 / 22 (4.55%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 myocardial infarction
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina Pectoris
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    1 / 70 (1.43%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Multiple Sclerosis Relapse
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 185 (2.16%)
    4 / 203 (1.97%)
    4 / 163 (2.45%)
    0 / 187 (0.00%)
    3 / 119 (2.52%)
    3 / 175 (1.71%)
    4 / 69 (5.80%)
    2 / 153 (1.31%)
    1 / 34 (2.94%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    3 / 70 (4.29%)
    0 / 8 (0.00%)
    2 / 48 (4.17%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 4
    0 / 0
    0 / 3
    0 / 3
    0 / 4
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 3
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle Spasticity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myasthenia Gravis
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Sclerosis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    2 / 163 (1.23%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    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
    Paraparesis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 myelopathy
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    1 / 48 (2.08%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Vision Blurred
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal Obstruction
         subjects affected / exposed
    2 / 185 (1.08%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    1 / 119 (0.84%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    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
    Enterocolitis
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocutaneous Fistula
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    1 / 70 (1.43%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    1 / 175 (0.57%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    1 / 70 (1.43%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis Acute
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus Ulcer
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 185 (1.08%)
    4 / 203 (1.97%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    2 / 175 (1.14%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    1 / 34 (2.94%)
    1 / 110 (0.91%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    1 / 48 (2.08%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary Retention
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 185 (0.54%)
    0 / 203 (0.00%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral Haemorrhage
         subjects affected / exposed
    0 / 185 (0.00%)
    1 / 203 (0.49%)
    0 / 163 (0.00%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress Urinary Incontinence
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    1 / 187 (0.53%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)
    0 / 5 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 Neck Obstruction
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    0 / 153 (0.00%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    0 / 185 (0.00%)
    0 / 203 (0.00%)
    1 / 163 (0.61%)
    0 / 187 (0.00%)
    0 / 119 (0.00%)
    0 / 175 (0.00%)
    0 / 69 (0.00%)
    1 / 153 (0.65%)
    0 / 34 (0.00%)
    0 / 110 (0.00%)
    0 / 16 (0.00%)
    0 / 70 (0.00%)
    0 / 8 (0.00%)
    0 / 48 (0.00%)
    0 / 36 (0.00%)
    0 / 22 (0.00%)
    0 / 11 (0.00%)