A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®... | NCT01852058 | Trialant
NCT01852058
Sponsor
Allergan
Status
Completed
Last Update Posted
May 12, 2020Actual
Enrollment
95Actual
Phase
Phase 3
Conditions
Urinary Incontinence
Interventions
OnabotulinumtoxinA
Countries
United States
Belgium
Canada
Czechia
France
Italy
Poland
Turkey (Türkiye)
Protocol Section
Identification Module
NCT ID
NCT01852058
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
191622-121
Secondary IDs
ID
Type
Description
Link
2012-004898-30
EudraCT Number
Brief Title
A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Official Title
Long-term Extension Study of BOTOX® in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Apr 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 11, 2014Actual
Primary Completion Date
Nov 22, 2018Actual
Completion Date
Oct 3, 2019Actual
First Submitted Date
May 9, 2013
First Submission Date that Met QC Criteria
May 9, 2013
First Posted Date
May 13, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 22, 2020
Results First Submitted that Met QC Criteria
Apr 22, 2020
Results First Posted Date
May 12, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Oct 2, 2019
Certification/Extension First Submitted that Passed QC Review
Oct 2, 2019
Certification/Extension First Posted Date
Oct 9, 2019Actual
Last Update Submitted Date
Apr 22, 2020
Last Update Posted Date
May 12, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will evaluate the long-term safety and efficacy of onabotulinumtoxinA (botulinum toxin Type A; BOTOX®) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in participants who successfully completed Study 191622-120 (NCT01852045).
Detailed Description
Not provided
Conditions Module
Conditions
Urinary Incontinence
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
95Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
OnabotulinumtoxinA 50 U
Experimental
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).
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA 100 U
Experimental
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).
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA 200 U
Experimental
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).
Biological: OnabotulinumtoxinA
Interventions
Name
Type
Description
Arm Group Labels
Other Names
OnabotulinumtoxinA
Biological
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
OnabotulinumtoxinA 100 U
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 under the respective treatments that participants received in the corresponding treatment cycle.
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
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.
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
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.
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Successfully completed participation in Study 191622-120
Aged ≥ 5 years to ≤ 17 years at the time of entry into Study 191622-120
Regularly using clean intermittent catheterization to empty the bladder
Exclusion Criteria:
Myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
Current or planned use of a baclofen pump
Current or planned use of an electrostimulation/neuromodulation device for urinary incontinence
Use of an indwelling catheter for urinary incontinence instead of using 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 for any other condition since entering study 191622-120
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
5 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
Brenda Jenkins
Allergan
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham Division of Urology Research Office
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).
Recruitment Details
Participants who successfully completed Study 191622-120 (NCT01852045) were enrolled in this study and were followed for up to an additional 60 weeks.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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).
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)
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
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.
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
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
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.
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
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
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.
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1
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.
Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2
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.
Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3
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.
Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
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.
Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
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.
Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
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.
Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
Average Time to Participant's Request for Retreatment
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.
First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)
Average Time to Participant's Qualification for Retreatment
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.
First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1
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.
Week 6 in Treatment Cycle 1
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2
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.
Week 6 in Treatment Cycle 2
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3
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.
Week 6 in Treatment Cycle 3
Cedars-Sinai Medical Center
Los Angeles
California
90048
United States
Children's Hospital of Orange County
Orange
California
92868
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Illinois
60611
United States
Riley Hospital for Children
Indianapolis
Indiana
46032
United States
William Beaumont Hospital Research Institute
Royal Oak
Michigan
48073
United States
St. Louis Children's Hospital Division of Urology
St Louis
Missouri
63110
United States
Pediatric Urology Associates, PC
Tarrytown
New York
10591
United States
McKay Urology Carolinas Medical Center
Charlotte
North Carolina
28207
United States
Duke University
Durham
North Carolina
27705
United States
Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic
Cincinnati
Ohio
45229
United States
Oklahoma Children's Hospital
Oklahoma City
Oklahoma
73104
United States
Medical University of South Carolina
Charleston
South Carolina
29425
United States
Children's Hospital of Wisconsin Department of Pediatric Urology
Milwaukee
Wisconsin
53226
United States
UZ Antwerpen
Antwerp
2650
Belgium
Ghent University Hospital
Ghent
9000
Belgium
UZ Leuven
Leuven
3000
Belgium
McMaster University Medical Centre
Hamilton
Ontario
L8S 4K1
Canada
CHU Sainte Justine
Montreal
Quebec
H3T 1C5
Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové
50005
Czechia
Fakultni nemocnice Olomouc
Olomouc
775 20
Czechia
Hopital Pellegrin - Enfants
Bordeaux
33076
France
CHU de Limoges - Hôpital Mère et l'Enfant
Limoges
87000
France
Hôpital Necker Enfants-Malades
Paris
75015
France
Seconda Università di Napoli
Naples
80138
Italy
Bambin Gesù- Ospedale Pediatrico
Rome
00165
Italy
Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed
Gdansk
80-803
Poland
Specjalistyczny Gabinet Lekarski
Poznan
61-512
Poland
Medical University of Wroclaw
Wroclaw
50-369
Poland
University of Ankara
Ankara
6100
Turkey (Türkiye)
FG001
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).
FG002
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).
FG003
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).
FG004
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).
FG005
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).
FG006
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).
FG007
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).
FG008
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).
FG009
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).
FG010
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).
FG011
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).
FG00031 subjects
FG00139 subjects
FG00225 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
Completed=Completed the entire study in this Cycle
FG00030 subjects
FG00139 subjects
FG00225 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Treatment Cycle2:Retreatment 1,Study 121
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0039 subjects
FG00445 subjects
FG00536 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
Completed=Completed the entire study in this Cycle
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Treatment Cycle3:Retreatment 2,Study 121
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG00716 subjects
FG00834 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
COMPLETED
Completed=Completed the entire study in this Cycle
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Treatment Cycle4:Retreatment 3,Study 121
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0104 subjects
FG0114 subjects
COMPLETED
Completed=Completed the entire study in this Cycle
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
BOTOX-treated Population included all participants enrolled into the 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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
OnabotulinumtoxinA 50 U
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).
BG001
OnabotulinumtoxinA 100 U
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).
BG002
OnabotulinumtoxinA 200 U
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).
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00031
BG00139
BG00225
BG00395
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00011.7± 3.49
BG00110.8± 3.36
BG00211.7± 3.22
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00114
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
White
BG00022
BG00128
BG002
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 under the respective treatments that participants received in the corresponding treatment cycle.
BOTOX-treated Population included all participants enrolled into the 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.
Posted
Mean
Standard Deviation
urinary incontinence episodes per day
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
ID
Title
Description
OG000
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).
OG001
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).
OG002
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).
Units
Counts
Participants
OG00031
OG00139
OG00225
Title
Denominators
Categories
Baseline
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00225
Title
Measurements
Primary
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2
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.
BOTOX-treated Population included all participants enrolled into the 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.
Posted
Mean
Standard Deviation
urinary incontinence episodes per day
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
ID
Title
Description
OG000
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).
OG001
Primary
Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3
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.
BOTOX-treated Population included all participants enrolled into the 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.
Posted
Mean
Standard Deviation
urinary incontinence episodes per day
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
ID
Title
Description
OG000
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).
OG001
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs)
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.
BOTOX-treated Population included all participants enrolled into the 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.
Posted
Count of Participants
Participants
First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)
ID
Title
Description
OG000
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).
Secondary
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
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
ID
Title
Description
OG000
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).
OG001
Secondary
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
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
ID
Title
Description
OG000
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).
OG001
Secondary
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
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
ID
Title
Description
OG000
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).
OG001
Secondary
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1
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.
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.
Posted
Mean
Standard Deviation
mL
Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
ID
Title
Description
OG000
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).
OG001
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).
Secondary
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2
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.
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.
Posted
Mean
Standard Deviation
mL
Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
ID
Title
Description
OG000
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).
OG001
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).
Secondary
Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3
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.
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.
Posted
Mean
Standard Deviation
mL
Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
ID
Title
Description
OG000
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).
OG001
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).
Secondary
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1
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.
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.
Posted
Number
percentage of participants
Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1
ID
Title
Description
OG000
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).
OG001
Secondary
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2
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.
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.
Posted
Number
percentage of participants
Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2
ID
Title
Description
OG000
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).
OG001
Secondary
Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3
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.
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.
Posted
Number
percentage of participants
Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3
ID
Title
Description
OG000
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).
OG001
Secondary
Average Time to Participant's Request for Retreatment
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.
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.
Posted
Median
Full Range
weeks
First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)
ID
Title
Description
OG000
OnabotulinumtoxinA 50 U
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).
OG001
OnabotulinumtoxinA 100 U
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).
Secondary
Average Time to Participant's Qualification for Retreatment
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.
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.
Posted
Median
95% Confidence Interval
weeks
First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)
ID
Title
Description
OG000
OnabotulinumtoxinA 50 U
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).
OG001
Secondary
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Week 6 in Treatment Cycle 1
ID
Title
Description
OG000
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).
OG001
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).
Secondary
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Week 6 in Treatment Cycle 2
ID
Title
Description
OG000
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).
OG001
OnabotulinumtoxinA 100 U (Treatment Cycle 2)
Secondary
Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3
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.
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.
Posted
Number
95% Confidence Interval
percentage of participants
Week 6 in Treatment Cycle 3
ID
Title
Description
OG000
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).
OG001
OnabotulinumtoxinA 100 U (Treatment Cycle 3)
Time Frame
First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks)
Description
BOTOX-treated Population included all participants enrolled into the extension study who received at least 1 BOTOX treatment over the course of the total evaluation period, starting from their first treatment in Study 191622-120. Data are summarized under the respective treatments that participants received in the corresponding treatment cycles.
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
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).
0
31
2
31
21
31
EG001
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).
0
39
3
39
31
39
EG002
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).
0
25
1
25
16
25
EG003
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).
0
9
0
9
7
9
EG004
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).
0
45
5
45
32
45
EG005
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).
0
36
6
36
27
36
EG006
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).
0
5
0
5
4
5
EG007
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).
0
16
1
16
10
16
EG008
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).
0
34
2
34
19
34
EG009
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).
0
3
0
3
3
3
EG010
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).
0
4
0
4
2
4
EG011
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).
0
4
0
4
4
4
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urinary tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected39 at risk
EG0020 affected25 at risk
EG0030 affected9 at risk
EG004
Encephalitis viral
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected39 at risk
EG0020 affected25 at risk
EG003
Arteriovenous fistula thrombosis
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Hydrocephalus
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected39 at risk
EG0020 affected25 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0021 affected25 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Bacterial diarrhoea
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Febrile infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Wound infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Fistula
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Hip deformity
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Foot deformity
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Device malfunction
Product Issues
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0012 affected39 at risk
EG0022 affected25 at risk
EG0031 affected9 at risk
EG0042 affected45 at risk
EG0053 affected36 at risk
EG0061 affected5 at risk
EG0070 affected16 at risk
EG0080 affected34 at risk
EG0090 affected3 at risk
EG0100 affected4 at risk
EG0110 affected4 at risk
Abdominal pain
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected39 at risk
EG0021 affected25 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected39 at risk
EG0020 affected25 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Pyrexia
General disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0015 affected39 at risk
EG0020 affected25 at risk
EG003
Suprapubic pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected39 at risk
EG0021 affected25 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0009 affected31 at risk
EG00113 affected39 at risk
EG0025 affected25 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0005 affected31 at risk
EG0017 affected39 at risk
EG0025 affected25 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0003 affected31 at risk
EG0014 affected39 at risk
EG0020 affected25 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected39 at risk
EG0024 affected25 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected39 at risk
EG0020 affected25 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0013 affected39 at risk
EG0021 affected25 at risk
EG003
Cystitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0021 affected25 at risk
EG003
Viral infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected39 at risk
EG0020 affected25 at risk
EG003
Tinea capitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected39 at risk
EG0021 affected25 at risk
EG003
Asymptomatic bacteriuria
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected39 at risk
EG0020 affected25 at risk
EG003
Influenza
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected39 at risk
EG0021 affected25 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected39 at risk
EG0021 affected25 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Eschar
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Blood urine present
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected39 at risk
EG0020 affected25 at risk
EG003
Protein urine present
Investigations
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0012 affected39 at risk
EG0020 affected25 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0011 affected39 at risk
EG0020 affected25 at risk
EG003
Headache
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0017 affected39 at risk
EG0022 affected25 at risk
EG003
Leukocyturia
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0013 affected39 at risk
EG0023 affected25 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0011 affected39 at risk
EG0021 affected25 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Testicular retraction
Reproductive system and breast disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected39 at risk
EG0020 affected25 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0012 affected39 at risk
EG0021 affected25 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0001 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0002 affected31 at risk
EG0011 affected39 at risk
EG0021 affected25 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA version 19.0
Systematic Assessment
Number of participants at risk in the OnabotulinumtoxinA 200 U (Treatment Cycle 2) arm group is based on the female population.
EG0000 affected31 at risk
EG0010 affected39 at risk
EG0020 affected25 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
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.
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
8 subjects
FG00438 subjects
FG00527 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
7 subjects
FG0059 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0043 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Protocol Deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Reason not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0057 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0065 subjects
FG00715 subjects
FG00833 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
Reason Not Specified
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0093 subjects
FG0104 subjects
FG0114 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
11.3
± 3.36
13
BG00344
Male
BG00014
BG00125
BG00212
BG00351
18
BG00368
Black or African American
BG0006
BG0013
BG0022
BG00311
Asian
BG0001
BG0012
BG0020
BG0033
Hispanic
BG0001
BG0013
BG0023
BG0037
Other
BG0001
BG0013
BG0022
BG0036
OG0002.66± 0.876
OG0012.97± 1.135
OG0023.99± 5.492
Change from Baseline to Week 6
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00223
Title
Measurements
OG000-1.19± 1.156
OG001-1.39± 1.585
OG002-2.19± 5.738
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).
OG002
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).
Units
Counts
Participants
OG0009
OG00145
OG00236
Title
Denominators
Categories
Baseline
ParticipantsOG0009
ParticipantsOG00145
ParticipantsOG00236
Title
Measurements
OG0002.57± 0.937
OG0012.80± 0.915
OG0023.83± 4.623
Change from Baseline to Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
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).
OG002
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).
Units
Counts
Participants
OG0005
OG00116
OG00234
Title
Denominators
Categories
Baseline
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00234
Title
Measurements
OG0002.48± 0.228
OG0012.94± 0.923
OG0023.80± 4.678
Change from Baseline to Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
OG001
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).
OG002
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).
OG003
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).
OG004
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).
OG005
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).
OG006
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).
OG007
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).
OG008
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).
OG009
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).
OG010
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).
OG011
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).
Units
Counts
Participants
OG00031
OG00139
OG00225
OG0039
OG00445
OG00536
OG0065
OG00716
OG00834
OG0093
OG0104
OG0114
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00023
OG00131
OG00219
OG0037
OG00434
OG00531
OG0064
OG00710
OG00821
OG0093
OG0102
OG0114
STEAEs
Title
Measurements
OG0002
OG0013
OG0021
OG003
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).
OG002
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).
Units
Counts
Participants
OG00031
OG00139
OG00225
Title
Denominators
Categories
≥50% Reduction from Baseline to Week 6
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00223
Title
Measurements
OG00053.3(34.33 to 71.66)
OG00155.6(38.10 to 72.06)
OG00252.2(30.59 to 73.18)
≥75% Reduction from Baseline to Week 6
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00223
Title
Measurements
OG000
≥90% Reduction from Baseline to Week 6
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00223
Title
Measurements
OG000
≥100% Reduction from Baseline to Week 6
ParticipantsOG00030
ParticipantsOG00136
ParticipantsOG00223
Title
Measurements
OG000
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).
OG002
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).
Units
Counts
Participants
OG0009
OG00145
OG00236
Title
Denominators
Categories
≥50% Reduction from Baseline to Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG00066.7(22.28 to 95.67)
OG00165.9(50.08 to 79.51)
OG00258.8(40.70 to 75.35)
≥75% Reduction from Baseline to Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
≥90% Reduction from Baseline to Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
≥100% Reduction from Baseline to Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
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).
OG002
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).
Units
Counts
Participants
OG0005
OG00116
OG00234
Title
Denominators
Categories
≥50% Reduction from Baseline at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG00060.0(14.66 to 94.73)
OG00175.0(47.62 to 92.73)
OG00269.7(51.29 to 84.41)
≥75% Reduction from Baseline at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
≥90% Reduction from Baseline at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
≥100% Reduction from Baseline at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
OG002
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).
Units
Counts
Participants
OG00030
OG00136
OG00221
Title
Denominators
Categories
Title
Measurements
OG00014.68± 88.146
OG00139.88± 72.787
OG00296.90± 120.429
OG002
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).
Units
Counts
Participants
OG0006
OG00143
OG00231
Title
Denominators
Categories
Title
Measurements
OG0007.92± 148.597
OG00179.53± 106.794
OG00235.34± 98.209
OG002
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).
Units
Counts
Participants
OG0005
OG00110
OG00231
Title
Denominators
Categories
Title
Measurements
OG00058.50± 22.749
OG00157.86± 74.762
OG00292.39± 147.322
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).
OG002
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).
Units
Counts
Participants
OG00031
OG00139
OG00225
Title
Denominators
Categories
0 Nights of Incontinence at Baseline
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00223
Title
Measurements
OG0000.0
OG00115.4
OG0024.3
0 Nights of Incontinence at Week 6
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00224
Title
Measurements
OG000
1 Night of Incontinence at Baseline
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00223
Title
Measurements
OG000
1 Night of Incontinence at Week 6
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00224
Title
Measurements
OG000
2 Nights of Incontinence at Baseline
ParticipantsOG00031
ParticipantsOG00139
ParticipantsOG00223
Title
Measurements
OG000
2 Nights of Incontinence at Week 6
ParticipantsOG00030
ParticipantsOG00137
ParticipantsOG00224
Title
Measurements
OG000
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).
OG002
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).
Units
Counts
Participants
OG0009
OG00145
OG00236
Title
Denominators
Categories
0 Nights of Incontinence at Baseline
ParticipantsOG0009
ParticipantsOG00145
ParticipantsOG00234
Title
Measurements
OG0000.0
OG0018.9
OG0025.9
0 Nights of Incontinence at Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
1 Night of Incontinence at Baseline
ParticipantsOG0009
ParticipantsOG00145
ParticipantsOG00234
Title
Measurements
OG000
1 Night of Incontinence at Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
2 Nights of Incontinence at Baseline
ParticipantsOG0009
ParticipantsOG00145
ParticipantsOG00234
Title
Measurements
OG000
2 Nights of Incontinence at Week 6
ParticipantsOG0006
ParticipantsOG00144
ParticipantsOG00234
Title
Measurements
OG000
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).
OG002
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).
Units
Counts
Participants
OG0005
OG00116
OG00234
Title
Denominators
Categories
0 Nights of Incontinence at Baseline
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00234
Title
Measurements
OG0000.0
OG00112.5
OG0025.9
0 Nights of Incontinence at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
1 Night of Incontinence at Baseline
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00234
Title
Measurements
OG000
1 Night of Incontinence at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
2 Nights of Incontinence at Baseline
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00234
Title
Measurements
OG000
2 Nights of Incontinence at Week 6
ParticipantsOG0005
ParticipantsOG00116
ParticipantsOG00233
Title
Measurements
OG000
OG002
OnabotulinumtoxinA 200 U
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).
Units
Counts
Participants
OG00030
OG00153
OG00235
Title
Denominators
Categories
Title
Measurements
OG00024.55(11.9 to 89.7)
OG00124.64(11.7 to 73.3)
OG00225.43(11.1 to 78.9)
OnabotulinumtoxinA 100 U
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).
OG002
OnabotulinumtoxinA 200 U
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).
Units
Counts
Participants
OG00029
OG00153
OG00225
Title
Denominators
Categories
Title
Measurements
OG00025.38(11.9 to 84.4)
OG00125.43(11.7 to 76.1)
OG00226.29(11.1 to 78.9)
OG002
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).
Units
Counts
Participants
OG00030
OG00135
OG00224
Title
Denominators
Categories
Title
Measurements
OG00080.0(61.43 to 92.29)
OG00180.0(63.06 to 91.56)
OG00275.0(53.29 to 90.23)
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).
OG002
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).
Units
Counts
Participants
OG0008
OG00142
OG00230
Title
Denominators
Categories
Title
Measurements
OG00075.0(34.91 to 96.81)
OG00197.6(87.43 to 99.94)
OG00283.3(65.28 to 94.36)
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).
OG002
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).