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Trial record 48 of 720 for:    Botulinum Toxins, Type A

Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00915525
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : December 18, 2015
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Overactive Bladder
Urinary Incontinence
Intervention Biological: botulinum toxin Type A
Enrollment 829
Recruitment Details This was a long-term follow-up study that enrolled patients after participation in the preceding studies 191622-095 (NCT00910845) and 191622-520 (NCT00910520). A total of 829 patients received at least 1 BOTOX treatment in Study 191622-096 or in the preceding studies.
Pre-assignment Details Following a planned interim analysis, the protocol was amended to remove the option to escalate to the 150U dose. The dose groups reflect the highest dose received (i.e. 100U BOTOX includes patients who only received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U at any time during the study).
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Period Title: Overall Study
Started 543 286
Completed 278 151
Not Completed 265 135
Reason Not Completed
Protocol Violation             9             4
Withdrawal by Subject             59             21
Lost to Follow-up             27             16
Pregnancy             2             0
Lack of Efficacy             15             32
Adverse Event             29             13
Missing             12             1
Other Reason             35             12
Site Closed             27             9
Retreat Request >Wk 144 (exclusionary)             4             5
Study Burden             28             12
Non-Compliance             3             1
Patient Moved             15             9
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U Total
Hide Arm/Group Description Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 543 286 829
Hide Baseline Analysis Population Description
BOTOX‐Treated population includes all patients enrolled in 191622-096 who received at least 1 BOTOX treatment in study 191622‐096, 191622‐095 or 191622‐520. Treatment groups reflect highest dose received (100U BOTOX includes patients who received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U).
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 543 participants 286 participants 829 participants
<40 years
39
   7.2%
23
   8.0%
62
   7.5%
40 to 64 years
276
  50.8%
147
  51.4%
423
  51.0%
65 to 74 years
156
  28.7%
74
  25.9%
230
  27.7%
≥75 years
72
  13.3%
42
  14.7%
114
  13.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 543 participants 286 participants 829 participants
Female
493
  90.8%
256
  89.5%
749
  90.3%
Male
50
   9.2%
30
  10.5%
80
   9.7%
1.Primary Outcome
Title Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Hide Description Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 829
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Study Baseline (BL) 5.55  (3.617)
Chg from Study BL at Wk 12 Tmt Cycle1 (N=812) -3.26  (3.439)
2.Primary Outcome
Title Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Hide Description Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 608 116
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Study Baseline (BL) 5.70  (3.685) 5.66  (3.798)
Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) -3.64  (3.402) -3.05  (3.690)
3.Primary Outcome
Title Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Hide Description Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 388 179
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Study Baseline (BL) 5.65  (3.380) 6.30  (4.280)
Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) -3.82  (3.341) -3.46  (3.771)
4.Primary Outcome
Title Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Hide Description Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 273 131
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Study Baseline (BL) 5.78  (3.463) 6.19  (4.140)
Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) -3.48  (3.733) -3.32  (3.972)
5.Primary Outcome
Title Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Hide Description Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 185 88
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Study Baseline (BL) 5.47  (3.283) 6.43  (3.622)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) -3.34  (3.791) -3.58  (3.266)
6.Primary Outcome
Title Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Hide Description Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 139 50
Mean (Standard Deviation)
Unit of Measure: Incontinence Episodes
Study Baseline (BL) 5.65  (3.238) 7.17  (4.223)
Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) -3.05  (3.493) -3.12  (3.753)
7.Primary Outcome
Title Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
Hide Description The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
Time Frame Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 812
Measure Type: Number
Unit of Measure: Percentage of Patients
74.0
8.Primary Outcome
Title Percentage of Patients With a Positive Response on the 4-Point TBS
Hide Description The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
Time Frame Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 594 110
Measure Type: Number
Unit of Measure: Percentage of Patients
81.3 71.8
9.Primary Outcome
Title Percentage of Patients With a Positive Response on the 4-Point TBS
Hide Description The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
Time Frame Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 374 173
Measure Type: Number
Unit of Measure: Percentage of Patients
82.1 71.1
10.Primary Outcome
Title Percentage of Patients With a Positive Response on the 4-Point TBS
Hide Description The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
Time Frame Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 263 123
Measure Type: Number
Unit of Measure: Percentage of Patients
78.3 81.3
11.Primary Outcome
Title Percentage of Patients With a Positive Response on the 4-Point TBS
Hide Description The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
Time Frame Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 179 86
Measure Type: Number
Unit of Measure: Percentage of Patients
83.2 81.4
12.Primary Outcome
Title Percentage of Patients With a Positive Response on the 4-Point TBS
Hide Description The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either “greatly improved” or “improved” are considered to have a positive response.
Time Frame Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 136 48
Measure Type: Number
Unit of Measure: Percentage of Patients
80.9 81.3
13.Secondary Outcome
Title Change From Study Baseline in the Daily Average Number of Micturition Episodes
Hide Description The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 829
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 11.70  (3.584)
Chg from Study BL at Wk 12 Tmt Cycle1 (N=812) -2.56  (2.887)
14.Secondary Outcome
Title Change From Study Baseline in the Daily Average Number of Micturition Episodes
Hide Description The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 608 116
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 11.83  (3.634) 11.48  (3.912)
Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) -2.89  (3.037) -2.31  (3.293)
15.Secondary Outcome
Title Change From Study Baseline in the Daily Average Number of Micturition Episodes
Hide Description The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 388 179
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 11.65  (3.553) 12.22  (3.760)
Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) -2.86  (3.058) -3.01  (3.217)
16.Secondary Outcome
Title Change From Study Baseline in the Daily Average Number of Micturition Episodes
Hide Description The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 273 131
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 11.68  (3.456) 11.82  (3.442)
Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) -2.69  (3.485) -2.78  (2.882)
17.Secondary Outcome
Title Change From Study Baseline in the Daily Average Number of Micturition Episodes
Hide Description The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 185 88
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 11.55  (3.261) 11.79  (2.770)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) -2.85  (3.181) -3.19  (2.772)
18.Secondary Outcome
Title Change From Study Baseline in the Daily Average Number of Micturition Episodes
Hide Description The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 139 50
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 11.85  (3.377) 11.81  (2.990)
Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) -2.76  (3.153) -2.66  (3.351)
19.Secondary Outcome
Title Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
Hide Description The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
Time Frame Study Baseline, Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 827
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 34.3  (18.58)
Chg from Study BL at Wk 12 Tmt Cycle1 (N=810) 26.0  (24.84)
20.Secondary Outcome
Title Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Hide Description The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time Frame Study Baseline, Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 606 116
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 33.8  (18.72) 32.8  (17.91)
Chg from Study BL at Wk 12 Tmt Cycle2 (N=586, 109) 28.6  (24.38) 21.6  (23.71)
21.Secondary Outcome
Title Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Hide Description The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time Frame Study Baseline, Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 386 179
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 33.8  (18.21) 31.9  (18.17)
Chg from Study BL at Wk 12 Tmt Cycle3 (N=371, 173) 27.6  (22.39) 23.7  (25.68)
22.Secondary Outcome
Title Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Hide Description The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time Frame Study Baseline, Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 271 131
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 31.4  (17.32) 32.5  (19.36)
Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 124) 27.3  (24.90) 20.3  (22.63)
23.Secondary Outcome
Title Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Hide Description The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time Frame Study Baseline, Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 184 88
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 31.2  (17.49) 31.9  (20.30)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86) 28.1  (23.75) 19.5  (21.43)
24.Secondary Outcome
Title Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
Hide Description The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Time Frame Study Baseline, Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 138 50
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 30.3  (17.87) 30.2  (20.28)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86) 22.6  (24.99) 18.3  (14.91)
25.Secondary Outcome
Title Change From Study Baseline in the King’s Health Questionnaire (KHQ) Role Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 824
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 64.3  (28.77)
Chg from Study BL at Wk 12 Tmt Cycle1 (N=813) -28.5  (34.32)
26.Secondary Outcome
Title Change From Study Baseline in the KHQ Role Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 605 115
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 64.5  (28.51) 66.2  (30.15)
Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109) -32.1  (34.29) -29.2  (35.94)
27.Secondary Outcome
Title Change From Study Baseline in the KHQ Role Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 387 177
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 64.7  (28.36) 63.4  (30.41)
Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171) -29.7  (33.47) -27.9  (34.57)
28.Secondary Outcome
Title Change From Study Baseline in the KHQ Role Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 272 130
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 66.3  (27.65) 62.3  (31.17)
Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123) -30.9  (33.82) -23.4  (33.05)
29.Secondary Outcome
Title Change From Study Baseline in the KHQ Role Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 185 87
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 65.4  (29.15) 62.6  (31.84)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85) -30.8  (35.13) -26.3  (28.45)
30.Secondary Outcome
Title Change From Study Baseline in the KHQ Role Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 138 50
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 66.4  (30.00) 60.3  (33.15)
Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48) -24.8  (38.93) -22.9  (25.64)
31.Secondary Outcome
Title Change From Study Baseline in the KHQ Social Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 824
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 43.1  (30.79)
Chg from Study BL at Wk 12 Tmt Cycle1 (N=813) -18.4  (29.46)
32.Secondary Outcome
Title Change From Study Baseline in the KHQ Social Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 605 115
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 43.0  (30.96) 48.4  (30.12)
Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109) -20.0  (29.12) -19.0  (28.55)
33.Secondary Outcome
Title Change From Study Baseline in the KHQ Social Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 387 177
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 42.8  (31.02) 45.4  (31.38)
Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171) -17.9  (29.26) -19.2  (28.31)
34.Secondary Outcome
Title Change From Study Baseline in the KHQ Social Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 272 130
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 44.7  (31.86) 43.2  (30.46)
Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123) -19.8  (31.26) -16.1  (23.17)
35.Secondary Outcome
Title Change From Study Baseline in the KHQ Social Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 185 87
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 44.4  (31.39) 43.4  (32.89)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85) -21.7  (28.47) -15.7  (24.52)
36.Secondary Outcome
Title Change From Study Baseline in the KHQ Social Limitations Domain
Hide Description The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Time Frame Study Baseline, Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 138 50
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Study Baseline (BL) 46.7  (32.72) 43.3  (32.56)
Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48) -17.0  (33.59) -17.6  (24.43)
37.Secondary Outcome
Title Change From Study Baseline in Daily Frequency of Urgency Episodes
Hide Description The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 1
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 829
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 8.55  (4.206)
Chg from Study BL at Wk 12 Tmt Cycle1 (N=812) -3.81  (4.031)
38.Secondary Outcome
Title Change From Study Baseline in Daily Frequency of Urgency Episodes
Hide Description The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 2
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 608 116
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 8.63  (4.188) 9.09  (4.764)
Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108) -4.07  (4.046) -3.96  (4.519)
39.Secondary Outcome
Title Change From Study Baseline in Daily Frequency of Urgency Episodes
Hide Description The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 3
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 388 179
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 8.62  (4.055) 9.28  (4.552)
Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170) -4.22  (4.120) -3.86  (4.332)
40.Secondary Outcome
Title Change From Study Baseline in Daily Frequency of Urgency Episodes
Hide Description The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 4
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 273 131
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 8.65  (3.951) 8.98  (4.241)
Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122) -3.92  (4.341) -3.50  (3.916)
41.Secondary Outcome
Title Change From Study Baseline in Daily Frequency of Urgency Episodes
Hide Description The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 5
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 185 88
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 8.67  (3.961) 8.89  (3.341)
Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85) -4.11  (4.549) -3.56  (3.576)
42.Secondary Outcome
Title Change From Study Baseline in Daily Frequency of Urgency Episodes
Hide Description The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Time Frame Study Baseline, Week 12 Treatment Cycle 6
Hide Outcome Measure Data
Hide Analysis Population Description
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Arm/Group Title Botulinum Toxin Type A 100U Botulinum Toxin Type A 150U
Hide Arm/Group Description:
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Overall Number of Participants Analyzed 139 50
Mean (Standard Deviation)
Unit of Measure: Number of Episodes
Study Baseline (BL) 8.98  (4.059) 8.84  (3.629)
Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48) -3.95  (4.662) -2.64  (4.112)
Time Frame [Not Specified]
Adverse Event Reporting Description BOTOX-Treated Population includes all patients who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520), and is used to assess adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs are reported by treatment cycle.
 
Arm/Group Title Botulinum Toxin Type A 100U Treatment Cycle 1 Botulinum Toxin Type A 100U Treatment Cycle 2 Botulinum Toxin Type A 150U Treatment Cycle 2 Botulinum Toxin Type A 100U Treatment Cycle 3 Botulinum Toxin Type A 150U Treatment Cycle 3 Botulinum Toxin Type A 100U Treatment Cycle 4 Botulinum Toxin Type A 150U Treatment Cycle 4 Botulinum Toxin Type A 100U Treatment Cycle 5 Botulinum Toxin Type A 150U Treatment Cycle 5 Botulinum Toxin Type A 100U Treatment Cycle 6 Botulinum Toxin Type A 150U Treatment Cycle 6 Botulinum Toxin Type A 100U Treatment Cycle 7 Botulinum Toxin Type A 150U Treatment Cycle 7 Botulinum Toxin Type A 100U Treatment Cycle 8 Botulinum Toxin Type A 150U Treatment Cycle 8 Botulinum Toxin Type A 100U Treatment Cycle 9 Botulinum Toxin Type A 150U Treatment Cycle 9 Botulinum Toxin Type A 100U Treatment Cycle 10 Botulinum Toxin Type A 150U Treatment Cycle 10 Botulinum Toxin Type A 100U Treatment Cycle 11 Botulinum Toxin Type A 100U Treatment Cycle 12 Botulinum Toxin Type A 100U Treatment Cycle 13
Hide Arm/Group Description Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks. Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
All-Cause Mortality
Botulinum Toxin Type A 100U Treatment Cycle 1 Botulinum Toxin Type A 100U Treatment Cycle 2 Botulinum Toxin Type A 150U Treatment Cycle 2 Botulinum Toxin Type A 100U Treatment Cycle 3 Botulinum Toxin Type A 150U Treatment Cycle 3 Botulinum Toxin Type A 100U Treatment Cycle 4 Botulinum Toxin Type A 150U Treatment Cycle 4 Botulinum Toxin Type A 100U Treatment Cycle 5 Botulinum Toxin Type A 150U Treatment Cycle 5 Botulinum Toxin Type A 100U Treatment Cycle 6 Botulinum Toxin Type A 150U Treatment Cycle 6 Botulinum Toxin Type A 100U Treatment Cycle 7 Botulinum Toxin Type A 150U Treatment Cycle 7 Botulinum Toxin Type A 100U Treatment Cycle 8 Botulinum Toxin Type A 150U Treatment Cycle 8 Botulinum Toxin Type A 100U Treatment Cycle 9 Botulinum Toxin Type A 150U Treatment Cycle 9 Botulinum Toxin Type A 100U Treatment Cycle 10 Botulinum Toxin Type A 150U Treatment Cycle 10 Botulinum Toxin Type A 100U Treatment Cycle 11 Botulinum Toxin Type A 100U Treatment Cycle 12 Botulinum Toxin Type A 100U Treatment Cycle 13
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin Type A 100U Treatment Cycle 1 Botulinum Toxin Type A 100U Treatment Cycle 2 Botulinum Toxin Type A 150U Treatment Cycle 2 Botulinum Toxin Type A 100U Treatment Cycle 3 Botulinum Toxin Type A 150U Treatment Cycle 3 Botulinum Toxin Type A 100U Treatment Cycle 4 Botulinum Toxin Type A 150U Treatment Cycle 4 Botulinum Toxin Type A 100U Treatment Cycle 5 Botulinum Toxin Type A 150U Treatment Cycle 5 Botulinum Toxin Type A 100U Treatment Cycle 6 Botulinum Toxin Type A 150U Treatment Cycle 6 Botulinum Toxin Type A 100U Treatment Cycle 7 Botulinum Toxin Type A 150U Treatment Cycle 7 Botulinum Toxin Type A 100U Treatment Cycle 8 Botulinum Toxin Type A 150U Treatment Cycle 8 Botulinum Toxin Type A 100U Treatment Cycle 9 Botulinum Toxin Type A 150U Treatment Cycle 9 Botulinum Toxin Type A 100U Treatment Cycle 10 Botulinum Toxin Type A 150U Treatment Cycle 10 Botulinum Toxin Type A 100U Treatment Cycle 11 Botulinum Toxin Type A 100U Treatment Cycle 12 Botulinum Toxin Type A 100U Treatment Cycle 13
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   71/829 (8.56%)   62/608 (10.20%)   7/116 (6.03%)   32/388 (8.25%)   13/179 (7.26%)   18/273 (6.59%)   8/131 (6.11%)   15/185 (8.11%)   4/88 (4.55%)   8/139 (5.76%)   3/50 (6.00%)   3/93 (3.23%)   0/27 (0.00%)   4/69 (5.80%)   0/11 (0.00%)   0/48 (0.00%)   0/7 (0.00%)   1/37 (2.70%)   1/2 (50.00%)   2/20 (10.00%)   1/5 (20.00%)   0/2 (0.00%) 
Blood and lymphatic system disorders                                             
Anaemia  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Iron Deficiency Anaemia  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Coagulopathy  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Cardiac disorders                                             
Supraventricular Tachycardia  1  2/829 (0.24%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Angina Pectoris  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  1/179 (0.56%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Atrial Fibrillation  1  1/829 (0.12%)  2/608 (0.33%)  0/116 (0.00%)  2/388 (0.52%)  0/179 (0.00%)  0/273 (0.00%)  1/131 (0.76%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Cardiac Failure Congestive  1  1/829 (0.12%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Coronary Artery Disease  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Myocardial Infarction  1  1/829 (0.12%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Palpitations * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Ventricular Tachycardia  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Arrhythmia  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Angina Unstable  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Stress Cardiomyopathy  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  1/179 (0.56%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Mitral Valve Prolapse  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Cardiac Arrest  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/2 (0.00%) 
Congenital, familial and genetic disorders                                             
Foramen Magnum Stenosis  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Congenital Diaphragmatic Hernia  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Ear and labyrinth disorders                                             
Vertigo * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Endocrine disorders                                             
Goitre  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Eye disorders                                             
Cataract  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Vitreous Floaters * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  1/131 (0.76%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                                             
Abdominal Pain * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  2/131 (1.53%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Abdominal Pain Lower * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Colitis  1  1/829 (0.12%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Crohn’s Disease  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Inguinal Hernia  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Pancreatitis  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  1/139 (0.72%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Volvulus  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Small Intestinal Obstruction  1  0/829 (0.00%)  3/608 (0.49%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  1/50 (2.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Gastrointestinal Haemorrhage  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Internal Hernia  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Large Intestine Polyp  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Upper Gastrointestinal Haemorrhage  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Diarrhoea * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  1/131 (0.76%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Enterovesical Fistula  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Haematemesis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  1/69 (1.45%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
General disorders                                             
Fatigue * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Non-Cardiac Chest Pain * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Chest Pain * 1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Hernia Obstructive  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Medical Device Complication  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Pyrexia * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Device Ineffective  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  1/179 (0.56%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Hepatobiliary disorders                                             
Cholelithiasis  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Cholecystitis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/2 (0.00%) 
Immune system disorders                                             
Drug Hypersensitivity * 1  0/829 (0.00%)  0/608 (0.00%)  1/116 (0.86%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Allergy to Plants  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Anaphylactic Shock  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Infections and infestations                                             
Pneumonia  1  3/829 (0.36%)  2/608 (0.33%)  0/116 (0.00%)  3/388 (0.77%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  2/185 (1.08%)  0/88 (0.00%)  0/139 (0.00%)  1/50 (2.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/2 (0.00%) 
Appendicitis  1  2/829 (0.24%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Cellulitis  1  2/829 (0.24%)  2/608 (0.33%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Appendiceal Abscess  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Diverticulitis  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Gastroenteritis Viral * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Urinary Tract Infection  1  0/829 (0.00%)  3/608 (0.49%)  0/116 (0.00%)  2/388 (0.52%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  1/139 (0.72%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Localised infection  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Lung Infection  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Sinusitis  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Infected Skin Ulcer  1  0/829 (0.00%)  0/608 (0.00%)  1/116 (0.86%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Staphylococcal Sepsis  1  0/829 (0.00%)  0/608 (0.00%)  1/116 (0.86%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Urosepsis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  2/179 (1.12%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Bacterial Sepsis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Cystitis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Pyelonephritis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Staphylococcal Infection  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Sepsis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  1/50 (2.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Arthritis Bacterial  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  1/139 (0.72%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Gastroenteritis  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  1/139 (0.72%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                                             
Comminuted Fracture  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Fall * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Femur Fracture  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/2 (0.00%) 
Lumbar Vertebral Fracture  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Pelvic Fracture  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Joint Dislocation  1  0/829 (0.00%)  2/608 (0.33%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Lower Limb Fracture  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Patella Fracture  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  1/69 (1.45%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Procedural Pain * 1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Stress Fracture  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Tibia Fracture  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Wound * 1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Humerus Fracture  1  0/829 (0.00%)  0/608 (0.00%)  1/116 (0.86%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Accidental Overdose  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Incisional Hernia  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Rib Fracture  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Ankle Fracture  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  1/179 (0.56%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Spinal Compression Fracture  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Wound Dehiscence * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  1/139 (0.72%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Post Procedural Haemorrhage  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  1/131 (0.76%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Forearm Fracture  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Upper Limb Fracture  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Radiation Injury  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  1/2 (50.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Investigations                                             
Sigmoidoscopy  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Aspartate Aminotransferase Increased  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Heart Rate Increased  1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                                             
Obesity * 1  2/829 (0.24%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  1/179 (0.56%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Diabetes Mellitus  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Hyperglycaemia  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Metabolic Acidosis  1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Dehydration  1  0/829 (0.00%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                                             
Osteoarthritis * 1  7/829 (0.84%)  8/608 (1.32%)  0/116 (0.00%)  2/388 (0.52%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  1/185 (0.54%)  1/88 (1.14%)  1/139 (0.72%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Arthralgia * 1  2/829 (0.24%)  1/608 (0.16%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  1/131 (0.76%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Arthritis * 1  2/829 (0.24%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  2/185 (1.08%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Spinal Column Stenosis  1  2/829 (0.24%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  1/93 (1.08%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  1/37 (2.70%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Foot Deformity * 1  1/829 (0.12%)  2/608 (0.33%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  1/131 (0.76%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Intervertebral Disc Protrusion  1  1/829 (0.12%)  1/608 (0.16%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Muscle Spasms * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Pain in Extremity * 1  1/829 (0.12%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Lumbar Spinal Stenosis  1  0/829 (0.00%)  2/608 (0.33%)  0/116 (0.00%)  0/388 (0.00%)  0/179 (0.00%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Back Pain * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  1/179 (0.56%)  1/273 (0.37%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)  0/50 (0.00%)  0/93 (0.00%)  0/27 (0.00%)  0/69 (0.00%)  0/11 (0.00%)  0/48 (0.00%)  0/7 (0.00%)  0/37 (0.00%)  0/2 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/2 (0.00%) 
Spinal Osteoarthritis * 1  0/829 (0.00%)  0/608 (0.00%)  0/116 (0.00%)  1/388 (0.26%)  0/179 (0.00%)  0/273 (0.00%)  0/131 (0.00%)  0/185 (0.00%)  0/88 (0.00%)  0/139 (0.00%)