OnabotulinumtoxinA for the Treatment of Urinary Incontine... | NCT02097121 | Trialant
NCT02097121
Sponsor
Allergan
Status
Terminated
Last Update Posted
Dec 28, 2022Actual
Enrollment
56Actual
Phase
Phase 3
Conditions
Urinary Incontinence
Urinary Bladder
Overactive
Interventions
BOTOX®
Countries
United States
Australia
Belgium
Canada
Czechia
France
Germany
Italy
Netherlands
Norway
Poland
South Africa
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02097121
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
191622-137
Secondary IDs
ID
Type
Description
Link
2014-000464-17
EudraCT Number
Brief Title
OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Overactive Bladder in Pediatric Patients (12 to 17)
Official Title
BOTOX® in the Treatment of Urinary Incontinence Due to Overactive Bladder in Patients 12 to 17 Years of Age
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Nov 2022
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
May 23, 2014Actual
Primary Completion Date
Feb 10, 2022Actual
Completion Date
Feb 10, 2022Actual
First Submitted Date
Mar 24, 2014
First Submission Date that Met QC Criteria
Mar 24, 2014
First Posted Date
Mar 26, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 7, 2022
Results First Submitted that Met QC Criteria
Nov 23, 2022
Results First Posted Date
Dec 28, 2022Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 23, 2022
Last Update Posted Date
Dec 28, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a multicenter, randomized, double-blind, parallel-group, multiple-dose study to evaluate the efficacy and safety of BOTOX in adolescents with urinary incontinence due to overactive bladder (OAB) with inadequate management with anticholinergic therapy. Participants were randomized in a 1:1:1 ratio to receive a single Tx of 25 U, 50 U, or 100 U BOTOX (not to exceed 6 U/kg) on Day 1, were seen after each treatment at Weeks 2, 6, and 12 post-treatment, and thereafter at alternating telephone and clinic visits every 6 weeks until they qualified for further retreatment/exited the study. Participants could receive multiple treatments dependent upon the number and timing of patient requests/qualification for retreatment. At each retreatment the investigator could keep the dose the same or increase it one dose level in a blinded fashion. Participants exited the study once 96 weeks have elapsed since entry on Day 1 and at least 12 weeks follow-up since their last study treatment had occurred.
Detailed Description
Not provided
Conditions Module
Conditions
Urinary Incontinence
Urinary Bladder
Overactive
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
56Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Botox 25 U
Experimental
Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Biological: BOTOX®
Botox 50 U
Experimental
Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Biological: BOTOX®
Botox 100 U
Experimental
Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Biological: BOTOX®
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BOTOX®
Biological
Each vial of BOTOX (Botulinum Toxin Type A) purified neurotoxin complex, formulation No. 9060X contains 100 U of Clostridium botulinum toxin Type A, 0.5 mg albumin (human), and 0.9 mg sodium chloride in a sterile, vacuum-dried form without a preservative. The study medication was to be reconstituted with 0.9% sodium chloride (preservative-free). The 10 mL of study drug was to be administered as 20 injections each of 0.5 mL. Under direct cystoscopic visualization, injections were to be distributed evenly across the detrusor wall and spaced approximately 1 cm apart. To avoid injecting the trigone, the injections were to be at least 1 cm above the trigone. The injection needle was to be inserted approximately 2 mm into the detrusor for each injection.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
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 per the respective treatments that participants received in the corresponding treatment cycle.
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Secondary Outcomes
Measure
Description
Time Frame
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Micturition was defined as toilet voids 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 micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Other Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Symptoms of overactive bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months
OAB symptoms not adequately managed by 1 or more anticholinergic agents
Exclusion Criteria
OAB caused by a neurological condition
Use of anticholinergics or other medications to treat OAB symptoms within 7 days
Current use of indwelling catheter or clean intermittent catheterization to empty the bladder
Previous or current use of botulinum toxin therapy of any serotype for any urological condition, or treatment with botulinum toxin of any serotype within 3 months for any other condition or use
Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
12 Years
Maximum Age
17 Years
Standard Ages
Child
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ALLERGAN INC.
Allergan
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Alaska Urological Institute /ID# 238189
Anchorage
Alaska
99503-3902
United States
Arkansas Children's Hospital /ID# 237787
References Module
Citations
Not provided
See Also Links
Label
URL
Additional information on study locations near you may be found at AllerganClinicalTrials.com.,To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Participants were randomized in a 1:1:1 ratio to 1 of 3 treatment arms. Randomization was stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or > 6 episodes over the 2-day bladder diary collection period).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Botox 25 U
Participants randomized to receive 25 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 5, 2014
Oct 7, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Botox 100 U
Botox 25 U
Botox 50 U
Botulinum Toxin Type A
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Participants recorded daytime urgency episodes 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 urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Percentage of Participants With Night Time Urinary Incontinence
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response.
At Week 12 in Treatment Cycle 1
Time to Participant's First Request for Retreatment
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit.
From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
Time to Participant's Qualification for Retreatment
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit.
From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
From the first dose of study drug until the last dose, up to 147 weeks
Little Rock
Arkansas
72202
United States
Children's Hospital Colorado /ID# 237621
Aurora
Colorado
80045
United States
Yale New Haven Hospital - Yale School of Medicine /ID# 238222
New Haven
Connecticut
06510-3206
United States
Orlando Health-Arnold Palmer Hospital for Children Pediatric Urology /ID# 235283
Orlando
Florida
32806
United States
Associated Urologist of North Carolina /ID# 235437
Universitaetsklinikum Schleswig-Holstein Campus Luebeck /ID# 234288
Lübeck
23538
Germany
AOU Universita degli Studi della Campania Luigi Vanvitelli /ID# 237308
Naples
80138
Italy
Radboud Universitair Medisch Centrum /ID# 237043
Nijmegen
Gelderland
6525 GA
Netherlands
Maastricht Universitair Medisch Centrum /ID# 237678
Maastricht
6229 HX
Netherlands
Oslo University Hospital /ID# 234434
Oslo
0372
Norway
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu /ID# 238166
Wroclaw
Lower Silesian Voivodeship
50-556
Poland
Specjalistyczny Gabinet Lekarski /ID# 235257
Poznan
61-512
Poland
Medical Concierge Centrum Medyczne /ID# 235200
Warsaw
02-798
Poland
St Georges Hospital /ID# 235316
Port Elizabeth
6001
South Africa
Manchester University NHS Foundation Trust /ID# 234380
Manchester
Lancashire
M13 9WL
United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 234819
Norwich
Norfolk
NR4 7UY
United Kingdom
NHS Greater Glasgow and Clyde /ID# 237430
Glasgow
Scotland
G12 0XH
United Kingdom
NHS Grampian /ID# 237379
Aberdeen
AB15 6RE
United Kingdom
Alder Hey Children's NHS Foundation Trust /ID# 237279
Liverpool
L12 2AP
United Kingdom
Royal Berkshire NHS Foundation Trust /ID# 236915
Reading
RG1 5AN
United Kingdom
Sheffield Children's NHS Foundation Trust /ID# 237854
Sheffield
S10 2TH
United Kingdom
FG001
Botox 50 U
Participants randomized to receive 50 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
FG002
Botox 100 U
Participants randomized to receive 100 Units (U) BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone. Posttreatment follow-up clinic visits occurred at Weeks 2, 6, and 12. Participants could request retreatment from Week 12 and 12 weeks after each subsequent treatment for up to 4 cycles. The retreatment dose was determined by the Investigator and could be at the same dose or at the next higher dose compared with the preceding treatment.
FG00019 subjects
FG00118 subjects
FG00219 subjects
Received Any Treatment
FG00019 subjects
FG00117 subjects
FG00219 subjects
Actual Treatment Received in Cycle 1
FG00018 subjects
FG00117 subjects
FG00220 subjectsOne participant randomized to 25 U BOTOX received 100 U BOTOX in Cycle 1 in error
Actual Treatment Received in Cycle 2
FG0001 subjects
FG00117 subjectsOne participant assigned to 100 U BOTOX received 50 U BOTOX in Cycle 2 in error
FG00228 subjectsOne participant assigned to 25 U BOTOX and two participants assigned to 50 U BOTOX received 100 U BOTOX in Cycle 2 in error
Actual Treatment Received in Cycle 3
FG0002 subjects
FG0017 subjects
FG00213 subjects
Actual Treatment Received in Cycle 4
FG0000 subjects
FG0011 subjects
FG0023 subjects
COMPLETED
FG00012 subjects
FG00112 subjects
FG0029 subjects
NOT COMPLETED
FG0007 subjects
FG0016 subjects
FG00210 subjects
Type
Comment
Reasons
Other, not specified
FG0004 subjects
FG0012 subjects
FG0023 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0023 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0022 subjects
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0022 subjects
The BOTOX-treated population (all participants enrolled into the study who received at least 1 BOTOX treatment) according to the dose received in the first treatment cycle.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
BG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
BG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG00117
BG00220
BG00355
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
<=18 years
BG00018
BG00117
BG00220
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00013.7± 1.49
BG00114.3± 1.86
BG002
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00016
BG00117
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
No
Title
Denominators
Categories
White
Title
Measurements
BG00012
BG00112
BG002
Daily Frequency of Daytime Urinary Incontinence Episodes
A bladder diary was used to log each daytime urgency episode over 2 consecutive days during screening.
Mean
Standard Deviation
number of episodes
Title
Denominators
Categories
Title
Measurements
BG0005.29± 3.447
BG001
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1
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 per the respective treatments that participants received in the corresponding treatment cycle.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
urinary incontinence episodes per day
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-1.37± 0.801
OG001-0.97± 0.811
OG002-2.35± 0.746
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used.
ANCOVA
= 0.3802
LS Mean Difference
-0.98
Standard Error of the Mean
1.107
2-Sided
95
-3.203
1.243
Superiority
Secondary
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Micturition Episodes
Micturition was defined as toilet voids 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 micturition episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
micturition episodes per day
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Change From Study Baseline in the Daily Average Frequency of Normalized Daytime Urgency Episodes
Participants recorded daytime urgency episodes 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 urgency episodes were averaged during the 2-day period. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
urgency episodes per day
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Percentage of Participants With Night Time Urinary Incontinence
Urinary incontinence was defined as involuntary loss of urine. Participants recorded night time urinary incontinence episodes in a bladder diary during 2 consecutive days in the week prior to the study visit. Night time is defined as the time between going to bed to sleep for the night and waking up to start the next day. The number of daily night time urinary incontinence episodes were averaged during the 2-day period. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Participants with analysis values at both baseline and Week 12
Posted
Number
percentage of participants
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Change From Study Baseline in the Daily Average Volume Voided Per Micturition (mL)
The volume per micturition was derived from the total urine volume voided over 1 daytime period during the 2-day bladder diary collection period divided by the number of voids in the same daytime period. Daytime is defined as the time between waking up to start the day and going to bed to sleep for the night. A negative change from Baseline indicates improvement. Data are summarized per the respective treatments that participants received in the corresponding treatment cycle.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
mL
From Baseline to 2 consecutive days in the week prior to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Change From Study Baseline in Pediatric Urinary Incontinence Quality of Life Total Score (PinQ)
The PinQ is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time) and a total sum score is calculated (from 0 to 80), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
units on a scale
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Change From Study Baseline in PinQ Item 'I am Worried That People Might Think my Clothes Smell Like Pee"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
units on a scale
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Change From Study Baseline in PinQ Item 'My Bladder Problem Makes me Feel Bad About Myself"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
units on a scale
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Change From Study Baseline in PinQ Item 'I Miss Out on Being With Friends Because of my Bladder Problems"
The Pediatric Urinary Incontinence Quality of (PinQ) is a 20-item questionnaire that asks about the participant's incontinence and its consequences in daily life and relationships. Items are answered on a Likert-type scale of 0 (no) to 4 (all of the time), with higher scores indicating lower health-related quality of life. A negative change from Baseline indicates improvement.
Participants with analysis values at both baseline and Week 12
Posted
Least Squares Mean
Standard Error
units on a scale
From Day 1 Prior to Treatment to Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Percentage of Participants With a Positive Treatment Response in the Modified Treatment Benefit Scale
The Modified Treatment Benefit Scale (Modified TBS) is a single-item scale designed to assess the change in the participant's overactive bladder (OAB) condition following treatment. The participant's current condition (urinary problems, urinary incontinence) is compared to their condition prior to receipt of any study treatment by selection of "greatly improved", "improved", "not changed" or "worsened". Participants who selected "greatly improved" or "improved" were considered to have a positive treatment response.
Participants with non-missing values at Week 12
Posted
Number
95% Confidence Interval
percentage of participants
At Week 12 in Treatment Cycle 1
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Secondary
Time to Participant's First Request for Retreatment
The time from the day of BOTOX treatment to the request for the subsequent treatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not request retreatment were treated as censored at the time of their last study visit or study exit.
BOTOX-treated participants who requested retreatment
Posted
Median
95% Confidence Interval
weeks
From the day of BOTOX treatment in Treatment Cycle 1 to the request for subsequent treatment
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Units
Counts
Secondary
Time to Participant's Qualification for Retreatment
The time from the day of BOTOX treatment to the qualification for retreatment was estimated using a Kaplan-Meier survival method for each treatment group. Participants who did not qualify for retreatment were treated as censored at the time of their last study visit or study exit.
BOTOX-treated participants who qualified for retreatment
Posted
Median
95% Confidence Interval
weeks
From the day of BOTOX treatment in Treatment Cycle 1 to the qualification for retreatment
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in Treatment Cycle 1
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in Treatment Cycle 1
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in Treatment Cycle 1
Units
Counts
Other Pre-specified
Number of Participants With Treatment Emergent Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
All participants enrolled into the study who received at least 1 BOTOX treatment
Posted
Count of Participants
Participants
No
From the first dose of study drug until the last dose, up to 147 weeks
ID
Title
Description
OG000
BOTOX 25 U (BOTOX-Treated Population)
Participants received 25 U BOTOX in a given Treatment Cycle
OG001
BOTOX 50 U (BOTOX-Treated Population)
Participants received 50 U BOTOX in a given Treatment Cycle
Time Frame
All-cause mortality is reported from enrollment to the end of study; median time on follow-up was up to 724 days. TEAEs/SAEs were collected from the first dose of study drug until the last dose, up to 147 weeks.
Description
For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
25 U BOTOX All
All participants who received 25 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
18
1
18
12
18
EG001
50 U BOTOX All
All participants who received 50 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
29
0
29
23
29
EG002
100 U BOTOX All
All participants who received 100 U BOTOX (not to exceed 6 U/kg), administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
33
1
33
24
33
EG003
25 U BOTOX Cycle 1
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
18
1
18
12
18
EG004
50 U BOTOX Cycle 1
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
17
0
17
12
17
EG005
100 U BOTOX Cycle 1
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 1, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
20
0
20
14
20
EG006
All BOTOX Cycle 1
All BOTOX-treated participants in Treatment Cycle 1
0
55
1
55
38
55
EG007
25 U BOTOX Cycle 2
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
1
0
1
1
1
EG008
50 U BOTOX Cycle 2
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
17
0
17
13
17
EG009
100 U BOTOX Cycle 2
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 2, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
28
1
28
18
28
EG010
All BOTOX Cycle 2
All BOTOX-treated participants in Treatment Cycle 2
0
46
1
46
32
46
EG011
25 U BOTOX Cycle 3
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
2
0
2
1
2
EG012
50 U BOTOX Cycle 3
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
7
0
7
3
7
EG013
100 U BOTOX Cycle 3
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 3, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
13
1
13
8
13
EG014
All BOTOX Cycle 3
All BOTOX-treated participants in Treatment Cycle 3
0
22
1
22
12
22
EG015
25 U BOTOX Cycle 4
Participants who received 25 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
0
0
0
0
0
EG016
50 U BOTOX Cycle 4
Participants who received 50 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
1
0
1
1
1
EG017
100 U BOTOX Cycle 4
Participants who received 100 U BOTOX (not to exceed 6 U/kg) in Treatment Cycle 4, administered via cystoscopy as 20 intradetrusor injections of 0.5 mL each, sparing the trigone.
0
3
0
3
1
3
EG018
All BOTOX Cycle 4
All BOTOX-treated participants in Treatment Cycle 4
0
4
0
4
2
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG0031 events1 affected18 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected20 at risk
EG0061 events1 affected55 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected46 at risk
EG0110 events0 affected2 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected13 at risk
EG0140 events0 affected22 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected1 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
MALAISE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ANXIETY DISORDER
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
SOCIAL PROBLEM
Social circumstances
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
PALLOR
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ANAEMIA
Blood and lymphatic system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected17 at risk
EG0050 events0 affected20 at risk
EG0060 events0 affected55 at risk
EG0070 events0 affected1 at risk
EG0080 events0 affected17 at risk
EG0090 events0 affected28 at risk
EG0100 events0 affected46 at risk
EG0111 events1 affected2 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected13 at risk
EG0141 events1 affected22 at risk
EG0150 events0 affected0 at risk
EG0160 events0 affected1 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
TACHYCARDIA
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
HYPERACUSIS
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
MISOPHONIA
Ear and labyrinth disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
EYE PAIN
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
OCULAR HYPERAEMIA
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected18 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
IRRITABLE BOWEL SYNDROME
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0013 events3 affected29 at risk
EG0020 events0 affected33 at risk
EG003
CHRONIC FATIGUE SYNDROME
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
FATIGUE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
ILLNESS
General disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
MALAISE
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
PAIN
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
PERIPHERAL SWELLING
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
PYREXIA
General disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
BACTERIURIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected33 at risk
EG003
FUNGAL SKIN INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected29 at risk
EG0022 events2 affected33 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0022 events2 affected33 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0014 events2 affected29 at risk
EG0028 events6 affected33 at risk
EG003
PARONYCHIA
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0013 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
TONSILLITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0014 events2 affected29 at risk
EG0021 events1 affected33 at risk
EG003
TRACHEOBRONCHITIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected18 at risk
EG00111 events6 affected29 at risk
EG0029 events6 affected33 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
VULVOVAGINAL CANDIDIASIS
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ANIMAL BITE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ANIMAL SCRATCH
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
CLAVICLE FRACTURE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
CONTUSION
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
FALL
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0022 events2 affected33 at risk
EG003
LIGAMENT SPRAIN
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
POST PROCEDURAL DISCOMFORT
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
POST PROCEDURAL HAEMORRHAGE
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
PROCEDURAL PAIN
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
TENDON INJURY
Injury, poisoning and procedural complications
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
BLOOD ALKALINE PHOSPHATASE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
BLOOD BILIRUBIN INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
CRYSTAL URINE PRESENT
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
CYTOMEGALOVIRUS TEST POSITIVE
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
EPSTEIN-BARR VIRUS TEST POSITIVE
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
RED BLOOD CELLS URINE POSITIVE
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
RESIDUAL URINE VOLUME
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
URINE LEUKOCYTE ESTERASE POSITIVE
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ABNORMAL WEIGHT GAIN
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
VITAMIN D DEFICIENCY
Metabolism and nutrition disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
BACK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0002 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
FLANK PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
JOINT SWELLING
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
MUSCULOSKELETAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
SACRAL PAIN
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
SPONDYLOLISTHESIS
Musculoskeletal and connective tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected29 at risk
EG0020 events0 affected33 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected29 at risk
EG0024 events4 affected33 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ANOREXIA NERVOSA
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
BLADDER DISCOMFORT
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
BLADDER SPASM
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected18 at risk
EG0015 events5 affected29 at risk
EG0023 events3 affected33 at risk
EG003
HAEMATURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0003 events2 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
LEUKOCYTURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0013 events2 affected29 at risk
EG0020 events0 affected33 at risk
EG003
POLLAKIURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
URETHRAL PAIN
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0022 events2 affected33 at risk
EG003
URINARY INCONTINENCE
Renal and urinary disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0022 events2 affected33 at risk
EG003
GENITAL PAIN
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
HAEMORRHAGIC OVARIAN CYST
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
HEAVY MENSTRUAL BLEEDING
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
OEDEMA GENITAL
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
VAGINAL HAEMORRHAGE
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
VULVOVAGINAL DISCOMFORT
Reproductive system and breast disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0022 events2 affected33 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0013 events1 affected29 at risk
EG0022 events2 affected33 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0021 events1 affected33 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
NAIL BED INFLAMMATION
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0021 events1 affected33 at risk
EG003
FLUSHING
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
HAEMATOMA
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected29 at risk
EG0020 events0 affected33 at risk
EG003
RAYNAUD'S PHENOMENON
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected29 at risk
EG0020 events0 affected33 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D059411
Lower Urinary Tract Symptoms
D020924
Urological Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D019274
Botulinum Toxins, Type A
Ancestor Terms
ID
Term
D001905
Botulinum Toxins
D008666
Metalloendopeptidases
D010450
Endopeptidases
D010447
Peptide Hydrolases
D006867
Hydrolases
D004798
Enzymes
D045762
Enzymes and Coenzymes
D045726
Metalloproteases
D001426
Bacterial Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D001427
Bacterial Toxins
D014118
Toxins, Biological
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
55
Between 18 and 65 years
BG0000
BG0010
BG0020
BG0030
>=65 years
BG0000
BG0010
BG0020
BG0030
14.0
± 1.75
BG00314.0± 1.69
14
BG00347
Male
BG0002
BG0010
BG0026
BG0038
17
BG00341
Black or African American
Title
Measurements
BG0000
BG0010
BG0020
BG0030
Asian
Title
Measurements
BG0000
BG0011
BG0020
BG0031
Hispanic
Title
Measurements
BG0000
BG0010
BG0020
BG0030
Other
Title
Measurements
BG0001
BG0011
BG0021
BG0033
Not reported
Title
Measurements
BG0002
BG0011
BG0021
BG0034
Unknown
Title
Measurements
BG0003
BG0012
BG0021
BG0036
3.54
± 2.696
BG0023.64± 2.951
BG0034.15± 3.100
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group as factor. A hierarchical analysis strategy to adjust for multiplicity was used.
ANCOVA
= 0.733
LS Mean Difference
0.4
Standard Error of the Mean
1.154
2-Sided
95
-1.921
2.712
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-1.84± 1.027
OG0010.31± 1.014
OG002-1.02± 0.983
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.5743
LS Mean Difference
0.82
Standard Error of the Mean
1.442
2-Sided
95
-2.082
3.713
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.1451
LS Mean Difference
2.15
Standard Error of the Mean
1.455
2-Sided
95
-0.769
5.078
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-1.85± 1.014
OG001-1.78± 0.998
OG002-2.18± 0.945
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.8206
LS Mean Difference
-0.33
Standard Error of the Mean
1.434
2-Sided
95
-3.205
2.551
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.9604
LS Mean Difference
0.07
Standard Error of the Mean
1.434
2-Sided
95
-2.807
2.95
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Baseline-0 nights
Title
Measurements
OG00022.2
OG00152.9
OG00235.0
Baseline-1 night
Title
Measurements
OG00027.8
OG00111.8
OG00215.0
Baseline-2 nights
Title
Measurements
OG00050.0
OG00135.3
OG00250.0
Week 12-0 nights
Title
Measurements
OG00050.0
OG00176.5
OG00250.0
Week 12-1 night
Title
Measurements
OG00022.2
OG0015.9
OG00215.0
Week 12-2 nights
Title
Measurements
OG00027.8
OG00117.6
OG00235.0
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-9.17± 15.924
OG00124.94± 17.047
OG00226.16± 15.900
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.1174
LS Mean Difference
35.33
Standard Error of the Mean
22.175
2-Sided
95
-9.207
79.873
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.1567
LS Mean Difference
34.11
Standard Error of the Mean
23.722
2-Sided
95
-13.536
81.76
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-6.96± 2.841
OG001-5.11± 3.243
OG002-8.28± 2.979
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.7481
LS Mean Difference
-1.32
Standard Error of the Mean
4.091
2-Sided
95
-9.553
6.909
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.6691
LS Mean Difference
1.85
Standard Error of the Mean
4.299
2-Sided
95
-6.799
10.498
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.238
OG001-0.37± 0.273
OG002-0.09± 0.251
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.9297
LS Mean Difference
-0.03
Standard Error of the Mean
0.343
2-Sided
95
-0.721
0.661
Superiority
OG000
OG001
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.3976
LS Mean Difference
-0.3
Standard Error of the Mean
0.357
2-Sided
95
-1.022
0.413
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-0.54± 0.209
OG001-0.15± 0.238
OG002-0.24± 0.220
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.3309
LS Mean Difference
0.3
Standard Error of the Mean
0.302
2-Sided
95
-0.311
0.904
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.2235
LS Mean Difference
0.39
Standard Error of the Mean
0.315
2-Sided
95
-0.245
1.024
Superiority
Units
Counts
Participants
OG00018
OG00117
OG00220
Title
Denominators
Categories
Title
Measurements
OG000-0.39± 0.193
OG001-0.24± 0.218
OG002-0.27± 0.201
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.6689
LS Mean Difference
0.12
Standard Error of the Mean
0.274
2-Sided
95
-0.434
0.67
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using an ANCOVA model with study baseline value as covariate, and treatment group and stratification (baseline daytime urinary urgency incontinence episodes [a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period]) as factors. A hierarchical analysis strategy to adjust for multiplicity was not implemented.
ANCOVA
= 0.6076
LS Mean Difference
0.15
Standard Error of the Mean
0.288
2-Sided
95
-0.431
0.729
Superiority
Units
Counts
Participants
OG00017
OG00117
OG00219
Title
Denominators
Categories
Title
Measurements
OG00052.9(27.81 to 77.02)
OG00170.6(44.04 to 89.69)
OG00268.4(43.45 to 87.42)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Treatment Difference of 100 U versus 25 U
Pairwise comparisons of 100 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period).
Cochran-Mantel-Haenszel
= 0.6092
Risk difference %
15.5
2-Sided
95
-18.94
46.19
Superiority
OG000
OG001
Treatment Difference of 50 U versus 25 U
Pairwise comparisons of 50 U versus 25 U of BOTOX up to Week 12 in Treatment Cycle 1 was evaluated using the Cochran-Mantel-Haenszel (CMH) method stratified by baseline daytime urinary urgency incontinence episodes (a total of ≤ 6 episodes or > 6 episodes over the 2-day diary collection period).
Cochran-Mantel-Haenszel
= 0.4824
Risk difference %
17.6
2-Sided
95
-16.2
48.9
Superiority
Participants
OG00017
OG00114
OG00217
Title
Denominators
Categories
Title
Measurements
OG00016.6(12.71 to 25.29)
OG00117.6(11.29 to 38.57)
OG00221.3(12.86 to 30.14)
Participants
OG00016
OG00114
OG00217
Title
Denominators
Categories
Title
Measurements
OG00022.5(13.57 to 36.29)
OG00118.1(12.29 to 52.57)
OG00224.1(12.86 to 41.57)
OG002
BOTOX 100 U (BOTOX-Treated Population)
Participants received 100 U BOTOX in a given Treatment Cycle