Trial Outcomes & Findings for A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NCT NCT01852058)
NCT ID: NCT01852058
Last Updated: 2020-05-12
Results Overview
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
95 participants
Primary outcome timeframe
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Results posted on
2020-05-12
Participant Flow
Participants who successfully completed Study 191622-120 (NCT01852045) were enrolled in this study and were followed for up to an additional 60 weeks.
Data from the participant's participation in this extension Study 191622-121 (121) were integrated with the corresponding participant's data from the preceding Study 191622-120 (120).
Participant milestones
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Cycle 1, Occurred in Study 120
STARTED
|
31
|
39
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle 1, Occurred in Study 120
COMPLETED
|
30
|
39
|
25
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle 1, Occurred in Study 120
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
STARTED
|
0
|
0
|
0
|
9
|
45
|
36
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
COMPLETED
|
0
|
0
|
0
|
8
|
38
|
27
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
NOT COMPLETED
|
0
|
0
|
0
|
1
|
7
|
9
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle3:Retreatment 2,Study 121
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
16
|
34
|
0
|
0
|
0
|
|
Treatment Cycle3:Retreatment 2,Study 121
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
15
|
33
|
0
|
0
|
0
|
|
Treatment Cycle3:Retreatment 2,Study 121
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Treatment Cycle4:Retreatment 3,Study 121
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
4
|
|
Treatment Cycle4:Retreatment 3,Study 121
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
4
|
4
|
|
Treatment Cycle4:Retreatment 3,Study 121
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Cycle 1, Occurred in Study 120
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
Protocol Deviation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle2:Retreatment 1,Study 121
Reason not Specified
|
0
|
0
|
0
|
0
|
1
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Cycle3:Retreatment 2,Study 121
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Cycle3:Retreatment 2,Study 121
Reason Not Specified
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Baseline characteristics by cohort
| Measure |
OnabotulinumtoxinA 50 U
n=31 Participants
Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U
n=39 Participants
Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U
n=25 Participants
Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 3.49 • n=5 Participants
|
10.8 years
STANDARD_DEVIATION 3.36 • n=7 Participants
|
11.7 years
STANDARD_DEVIATION 3.22 • n=5 Participants
|
11.3 years
STANDARD_DEVIATION 3.36 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
22 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1Population: BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with evaluable data at the given timepoint.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=31 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=39 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Baseline
|
2.66 urinary incontinence episodes per day
Standard Deviation 0.876
|
2.97 urinary incontinence episodes per day
Standard Deviation 1.135
|
3.99 urinary incontinence episodes per day
Standard Deviation 5.492
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
Change from Baseline to Week 6
|
-1.19 urinary incontinence episodes per day
Standard Deviation 1.156
|
-1.39 urinary incontinence episodes per day
Standard Deviation 1.585
|
-2.19 urinary incontinence episodes per day
Standard Deviation 5.738
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2Population: BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with evaluable data at the given time point.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=9 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=45 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=36 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
Baseline
|
2.57 urinary incontinence episodes per day
Standard Deviation 0.937
|
2.80 urinary incontinence episodes per day
Standard Deviation 0.915
|
3.83 urinary incontinence episodes per day
Standard Deviation 4.623
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
Change from Baseline to Week 6
|
-1.07 urinary incontinence episodes per day
Standard Deviation 2.092
|
-1.70 urinary incontinence episodes per day
Standard Deviation 1.331
|
-1.64 urinary incontinence episodes per day
Standard Deviation 1.906
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3Population: BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with evaluable data at the given time point.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily daytime incontinence episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=5 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=16 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=34 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
Baseline
|
2.48 urinary incontinence episodes per day
Standard Deviation 0.228
|
2.94 urinary incontinence episodes per day
Standard Deviation 0.923
|
3.80 urinary incontinence episodes per day
Standard Deviation 4.678
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
Change from Baseline to Week 6
|
-1.92 urinary incontinence episodes per day
Standard Deviation 0.858
|
-1.73 urinary incontinence episodes per day
Standard Deviation 1.057
|
-2.74 urinary incontinence episodes per day
Standard Deviation 4.833
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)Population: BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 120.
An adverse event is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. A serious adverse event (SAE) is any AE that resulted in death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. A TEAE or STEAE is defined as any new AE or worsening of an existing condition after initiation of treatment. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=31 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=39 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
n=9 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
n=45 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
n=36 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
n=5 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
n=16 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
n=34 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
n=3 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
n=4 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
n=4 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
TEAEs
|
23 Participants
|
31 Participants
|
19 Participants
|
7 Participants
|
34 Participants
|
31 Participants
|
4 Participants
|
10 Participants
|
21 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
STEAEs
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1Population: BOTOX-treated Population included all participants enrolled into extension study who received at least 1 BOTOX treatment over the course of total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with evaluable data for the specific category.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily incontinence episodes were averaged during the 2-day period. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=31 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=39 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1
≥75% Reduction from Baseline to Week 6
|
30.0 percentage of participants
Interval 14.73 to 49.4
|
41.7 percentage of participants
Interval 25.51 to 59.24
|
39.1 percentage of participants
Interval 19.71 to 61.46
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1
≥50% Reduction from Baseline to Week 6
|
53.3 percentage of participants
Interval 34.33 to 71.66
|
55.6 percentage of participants
Interval 38.1 to 72.06
|
52.2 percentage of participants
Interval 30.59 to 73.18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1
≥90% Reduction from Baseline to Week 6
|
26.7 percentage of participants
Interval 12.28 to 45.89
|
30.6 percentage of participants
Interval 16.35 to 48.11
|
30.4 percentage of participants
Interval 13.21 to 52.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 1
≥100% Reduction from Baseline to Week 6
|
26.7 percentage of participants
Interval 12.28 to 45.89
|
27.8 percentage of participants
Interval 14.2 to 45.19
|
26.1 percentage of participants
Interval 10.23 to 48.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2Population: BOTOX-treated Population included all participants enrolled into extension study who received at least 1 BOTOX treatment over the course of total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with evaluable data for the specific category.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily incontinence episodes were averaged during the 2-day period. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=9 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=45 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=36 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2
≥50% Reduction from Baseline to Week 6
|
66.7 percentage of participants
Interval 22.28 to 95.67
|
65.9 percentage of participants
Interval 50.08 to 79.51
|
58.8 percentage of participants
Interval 40.7 to 75.35
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2
≥75% Reduction from Baseline to Week 6
|
50.0 percentage of participants
Interval 11.81 to 88.19
|
43.2 percentage of participants
Interval 28.35 to 58.97
|
47.1 percentage of participants
Interval 29.78 to 64.87
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2
≥90% Reduction from Baseline to Week 6
|
50.0 percentage of participants
Interval 11.81 to 88.19
|
27.3 percentage of participants
Interval 14.96 to 42.79
|
41.2 percentage of participants
Interval 24.65 to 59.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 2
≥100% Reduction from Baseline to Week 6
|
50.0 percentage of participants
Interval 11.81 to 88.19
|
25.0 percentage of participants
Interval 13.19 to 40.34
|
38.2 percentage of participants
Interval 22.17 to 56.44
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3Population: BOTOX-treated Population included all participants enrolled into extension study who received at least 1 BOTOX treatment over the course of total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with evaluable data for the specific category.
Urinary incontinence was defined as involuntary loss of urine as recorded by the participant in a bladder diary during 2 consecutive days in the week prior to the study visit (normalized to a 12 hour daytime period). Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. The number of daily incontinence episodes were averaged during the 2-day period. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=5 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=16 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=34 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3
≥75% Reduction from Baseline at Week 6
|
60.0 percentage of participants
Interval 14.66 to 94.73
|
37.5 percentage of participants
Interval 15.2 to 64.57
|
39.4 percentage of participants
Interval 22.91 to 57.86
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3
≥50% Reduction from Baseline at Week 6
|
60.0 percentage of participants
Interval 14.66 to 94.73
|
75.0 percentage of participants
Interval 47.62 to 92.73
|
69.7 percentage of participants
Interval 51.29 to 84.41
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3
≥90% Reduction from Baseline at Week 6
|
60.0 percentage of participants
Interval 14.66 to 94.73
|
18.8 percentage of participants
Interval 4.05 to 45.65
|
33.3 percentage of participants
Interval 17.96 to 51.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With ≥ 50%, ≥ 75%, ≥ 90%, and ≥ 100% Reduction From Baseline in the Number of Normalized Daytime Urinary Incontinence Episodes in Treatment Cycle 3
≥100% Reduction from Baseline at Week 6
|
60.0 percentage of participants
Interval 14.66 to 94.73
|
18.8 percentage of participants
Interval 4.05 to 45.65
|
30.3 percentage of participants
Interval 15.59 to 48.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. The daily values were averaged during the 2-day period. A positive change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=30 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=36 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=21 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1
|
14.68 mL
Standard Deviation 88.146
|
39.88 mL
Standard Deviation 72.787
|
96.90 mL
Standard Deviation 120.429
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. The daily values were averaged during the 2-day period. A positive change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=6 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=43 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=31 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2
|
7.92 mL
Standard Deviation 148.597
|
79.53 mL
Standard Deviation 106.794
|
35.34 mL
Standard Deviation 98.209
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
The change in urine volume at first morning catherization was recorded by the participant in a bladder diary in the 2 consecutive days during the week prior to the study visit. The daily values were averaged during the 2-day period. A positive change from Baseline indicates improvement. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=5 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=10 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=31 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3
|
58.50 mL
Standard Deviation 22.749
|
57.86 mL
Standard Deviation 74.762
|
92.39 mL
Standard Deviation 147.322
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1Population: BOTOX-treated Population included all participants enrolled into extension study who received \>= 1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with data available for analyses at the given time point.
Urinary incontinence was defined as involuntary loss of urine. Night time urinary incontinence was recorded by the participant on the bladder diary as a presence or absence of urinary leakage upon waking, for 2 consecutive days in the week prior to the week 6 visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories 0, 1, and 2 nights. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=31 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=39 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
1 Night of Incontinence at Week 6
|
20.0 percentage of participants
|
16.2 percentage of participants
|
29.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
0 Nights of Incontinence at Baseline
|
0.0 percentage of participants
|
15.4 percentage of participants
|
4.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
0 Nights of Incontinence at Week 6
|
30.0 percentage of participants
|
37.8 percentage of participants
|
25.0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
1 Night of Incontinence at Baseline
|
12.9 percentage of participants
|
2.6 percentage of participants
|
17.4 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
2 Nights of Incontinence at Baseline
|
87.1 percentage of participants
|
82.1 percentage of participants
|
78.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
2 Nights of Incontinence at Week 6
|
50.0 percentage of participants
|
45.9 percentage of participants
|
45.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2Population: BOTOX-treated Population included all participants enrolled into extension study who received \>= 1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with data available for analyses at the given time point.
Urinary incontinence was defined as involuntary loss of urine. Night time urinary incontinence was recorded by the participant on the bladder diary as a presence or absence of urinary leakage upon waking, for 2 consecutive days in the week prior to the week 6 visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories 0, 1, and 2 nights. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=9 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=45 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=36 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
1 Night of Incontinence at Baseline
|
22.2 percentage of participants
|
6.7 percentage of participants
|
8.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
1 Night of Incontinence at Week 6
|
16.7 percentage of participants
|
22.7 percentage of participants
|
8.8 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
2 Nights of Incontinence at Week 6
|
16.7 percentage of participants
|
43.2 percentage of participants
|
67.6 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
0 Nights of Incontinence at Baseline
|
0.0 percentage of participants
|
8.9 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
0 Nights of Incontinence at Week 6
|
66.7 percentage of participants
|
34.1 percentage of participants
|
23.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
2 Nights of Incontinence at Baseline
|
77.8 percentage of participants
|
84.4 percentage of participants
|
85.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3Population: BOTOX-treated Population included all participants enrolled into extension study who received \>= 1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Number analyzed is the number of participants with data available for analyses at the given time point.
Urinary incontinence was defined as involuntary loss of urine. Night time urinary incontinence was recorded by the participant on the bladder diary as a presence or absence of urinary leakage upon waking, for 2 consecutive days in the week prior to the week 6 visit. Night time was defined as the time between going to bed to sleep for the night and waking up to start the day. The percentage of participants with night time urinary incontinence is presented in categories 0, 1, and 2 nights. Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=5 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=16 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=34 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
0 Nights of Incontinence at Baseline
|
0.0 percentage of participants
|
12.5 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
0 Nights of Incontinence at Week 6
|
20.0 percentage of participants
|
31.3 percentage of participants
|
21.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
1 Night of Incontinence at Baseline
|
0.0 percentage of participants
|
0.0 percentage of participants
|
5.9 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
1 Night of Incontinence at Week 6
|
40.0 percentage of participants
|
12.5 percentage of participants
|
27.3 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
2 Nights of Incontinence at Week 6
|
40.0 percentage of participants
|
56.3 percentage of participants
|
51.5 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
2 Nights of Incontinence at Baseline
|
100.0 percentage of participants
|
87.5 percentage of participants
|
88.2 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
Time to request for re-treatment is the time in weeks between last injection and request for next injection, regardless of fulfillment of the re-treatment criteria. Data are summarized under the respective treatments that participants received across entire study. Data is reported for only participants that had at least one request for retreatment while on a specified BOTOX dose.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=30 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=35 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Average Time to Participant's Request for Retreatment
|
24.55 weeks
Interval 11.9 to 89.7
|
24.64 weeks
Interval 11.7 to 73.3
|
25.43 weeks
Interval 11.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period, starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
The criteria for qualification of retreatment included 1) Participant/parent/caregiver requests retreatment; 2) Participant has a total of at least 2 daytime urinary incontinence episodes over the 2-day bladder diary collection period; 3) At least 12 weeks has elapsed since treatment 1 and 4) Participant has not experienced a serious treatment-related adverse event at any time. Data are summarized under the respective treatments that participants received across entire study. Data is reported for only participants that had at least one request for retreatment while on a specified BOTOX dose.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=29 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=53 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Average Time to Participant's Qualification for Retreatment
|
25.38 weeks
Interval 11.9 to 84.4
|
25.43 weeks
Interval 11.7 to 76.1
|
26.29 weeks
Interval 11.1 to 78.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6 in Treatment Cycle 1Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period,starting from their first treatment in Study 120. Overall number of participants analyzed is number of participants with data available for analyses.
The Modified TBS is a single-item scale which assesses the participant's condition (urinary problems, urinary incontinence) on a 4-point scale where 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. A participant was considered to have a positive treatment response if they responded to the TBS question as either "greatly improved" or "improved". Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=30 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=35 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=24 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1
|
80.0 percentage of participants
Interval 61.43 to 92.29
|
80.0 percentage of participants
Interval 63.06 to 91.56
|
75.0 percentage of participants
Interval 53.29 to 90.23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6 in Treatment Cycle 2Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period,starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
The Modified TBS is a single-item scale which assesses the participant's condition (urinary problems, urinary incontinence) on a 4-point scale where 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. A participant was considered to have a positive treatment response if they responded to the TBS question as either "greatly improved" or "improved". Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=8 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=42 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=30 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2
|
75.0 percentage of participants
Interval 34.91 to 96.81
|
97.6 percentage of participants
Interval 87.43 to 99.94
|
83.3 percentage of participants
Interval 65.28 to 94.36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 6 in Treatment Cycle 3Population: BOTOX-treated Population included all participants enrolled into extension study who received \>=1 BOTOX treatment over course of total evaluation period,starting from their first treatment in Study 120. Overall number of participants analyzed is the number of participants with data available for analyses.
The Modified TBS is a single-item scale which assesses the participant's condition (urinary problems, urinary incontinence) on a 4-point scale where 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. A participant was considered to have a positive treatment response if they responded to the TBS question as either "greatly improved" or "improved". Data are summarized under the respective treatments that participants received in the corresponding treatment cycle.
Outcome measures
| Measure |
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=5 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=15 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=33 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3
|
100 percentage of participants
Interval 47.82 to 100.0
|
80.0 percentage of participants
Interval 51.91 to 95.67
|
84.8 percentage of participants
Interval 68.1 to 94.89
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
Serious events: 5 serious events
Other events: 32 other events
Deaths: 0 deaths
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
Serious events: 6 serious events
Other events: 27 other events
Deaths: 0 deaths
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
n=16 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
n=5 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=31 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=39 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
n=9 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
n=45 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
n=36 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
n=34 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
n=3 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
n=4 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
n=4 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Febrile infection
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.9%
2/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Vascular disorders
Hypertension
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Wound infection
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Musculoskeletal and connective tissue disorders
Hip deformity
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Product Issues
Device malfunction
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Nervous system disorders
Epilepsy
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
Other adverse events
| Measure |
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
n=16 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 3)
n=5 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 1)
n=31 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 1)
n=39 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 1)
n=25 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 2)
n=9 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
n=45 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 2)
n=36 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 3)
n=34 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 50 U (Treatment Cycle 4)
n=3 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 100 U (Treatment Cycle 4)
n=4 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
OnabotulinumtoxinA 200 U (Treatment Cycle 4)
n=4 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
20.0%
1/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
7.7%
3/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
12.0%
3/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
22.2%
2/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.3%
3/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
33.3%
1/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.9%
2/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Reproductive system and breast disorders
Testicular retraction
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.9%
2/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
5/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
20.0%
1/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.0%
2/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.3%
3/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.7%
3/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
22.2%
2/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
4/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
29.0%
9/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
33.3%
13/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
20.0%
5/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
48.9%
22/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
16.7%
6/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
17.6%
6/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
33.3%
1/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.7%
3/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
General disorders
Pyrexia
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
12.8%
5/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
13.3%
6/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.3%
3/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.8%
3/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
General disorders
Suprapubic pain
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Bacteriuria
|
18.8%
3/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
16.1%
5/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
17.9%
7/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
20.0%
5/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
20.0%
9/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.8%
4/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
66.7%
2/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Pharyngitis
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
9.7%
3/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
10.3%
4/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.7%
3/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
16.0%
4/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.3%
3/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
7.7%
3/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
22.2%
2/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
7.7%
3/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Cystitis
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Viral infection
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Influenza
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.9%
4/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.8%
1/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
25.0%
1/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.0%
1/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
4.4%
2/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Injury, poisoning and procedural complications
Eschar
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.2%
1/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Investigations
Blood urine present
|
6.2%
1/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
40.0%
2/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
22.2%
2/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.9%
4/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
14.7%
5/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
66.7%
2/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
50.0%
2/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
50.0%
2/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Investigations
Protein urine present
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
3.2%
1/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.1%
2/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.6%
1/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
40.0%
2/5 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.5%
2/31 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
17.9%
7/39 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
8.0%
2/25 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
11.1%
1/9 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
6.7%
3/45 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
5.6%
2/36 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
2.9%
1/34 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/3 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
0.00%
0/4 • First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER