A Long-Term Extension Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity
Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01852058
Collaborator
(none)
95
30
3
68.7
3.2
0
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
95 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jan 11, 2014
Actual Primary Completion Date
:
Nov 22, 2018
Actual Study Completion Date
:
Oct 3, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Other Names:
|
| Experimental: 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). |
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Other Names:
|
| Experimental: 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). |
Biological: OnabotulinumtoxinA
OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 [Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2 [Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3 [Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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 Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs) [First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks)]
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.
- 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 [Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- 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 [Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- 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 [Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1 [Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2 [Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3 [Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 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.
- Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1 [Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 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.
- Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2 [Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 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.
- Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3 [Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 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.
- Average Time to Participant's Request for Retreatment [First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)]
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.
- Average Time to Participant's Qualification for Retreatment [First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks)]
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.
- Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1 [Week 6 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.
- Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2 [Week 6 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.
- Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3 [Week 6 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham Division of Urology Research Office | Birmingham | Alabama | United States | 35294 |
| 2 | Cedars-Sinai Medical Center | Los Angeles | California | United States | 90048 |
| 3 | Children's Hospital of Orange County | Orange | California | United States | 92868 |
| 4 | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | United States | 60611 |
| 5 | Riley Hospital for Children | Indianapolis | Indiana | United States | 46032 |
| 6 | William Beaumont Hospital Research Institute | Royal Oak | Michigan | United States | 48073 |
| 7 | St. Louis Children's Hospital Division of Urology | Saint Louis | Missouri | United States | 63110 |
| 8 | Pediatric Urology Associates, PC | Tarrytown | New York | United States | 10591 |
| 9 | McKay Urology Carolinas Medical Center | Charlotte | North Carolina | United States | 28207 |
| 10 | Duke University | Durham | North Carolina | United States | 27705 |
| 11 | Cincinnati Children's Hospital Medical Center Cincinnati Center for Clinical Research and Outpatient Clinic | Cincinnati | Ohio | United States | 45229 |
| 12 | Oklahoma Children's Hospital | Oklahoma City | Oklahoma | United States | 73104 |
| 13 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 14 | Children's Hospital of Wisconsin Department of Pediatric Urology | Milwaukee | Wisconsin | United States | 53226 |
| 15 | UZ Antwerpen | Antwerpen | Belgium | 2650 | |
| 16 | Ghent University Hospital | Gent | Belgium | 9000 | |
| 17 | UZ Leuven | Leuven | Belgium | 3000 | |
| 18 | McMaster University Medical Centre | Hamilton | Ontario | Canada | L8S 4K1 |
| 19 | CHU Sainte Justine | Montreal | Quebec | Canada | H3T 1C5 |
| 20 | Fakultni nemocnice Hradec Kralove | Hradec Kralove | Czechia | 50005 | |
| 21 | Fakultni nemocnice Olomouc | Olomouc | Czechia | 775 20 | |
| 22 | Hopital Pellegrin - Enfants | Bordeaux | France | 33076 | |
| 23 | CHU de Limoges - Hôpital Mère et l'Enfant | Limoges | France | 87000 | |
| 24 | Hôpital Necker Enfants-Malades | Paris | France | 75015 | |
| 25 | Seconda Università di Napoli | Naples | Italy | 80138 | |
| 26 | Bambin Gesù- Ospedale Pediatrico | Rome | Italy | 00165 | |
| 27 | Copernicus Podmiot Leczniczy Sp. z o. o. Kliniczny Oddział Chirurgii i Urologii Dzieci i Młodzieży GUMed | Gdansk | Poland | 80-803 | |
| 28 | Specjalistyczny Gabinet Lekarski | Poznań | Poland | 61-512 | |
| 29 | Medical University of Wroclaw | Wroclaw | Poland | 50-369 | |
| 30 | University of Ankara | Ankara | Turkey | 6100 |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Brenda Jenkins, Allergan
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01852058
Other Study ID Numbers:
- 191622-121
- 2012-004898-30
First Posted:
May 13, 2013
Last Update Posted:
May 12, 2020
Last Verified:
Apr 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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. |
|---|---|
| Pre-assignment Detail | 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). |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) | OnabotulinumtoxinA 50 U (Treatment Cycle 4) | OnabotulinumtoxinA 100 U (Treatment Cycle 4) | OnabotulinumtoxinA 200 U (Treatment Cycle 4) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Period Title: Treatment Cycle 1, Occurred in Study 120 | ||||||||||||
| STARTED | 31 | 39 | 25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 30 | 39 | 25 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Treatment Cycle 1, Occurred in Study 120 | ||||||||||||
| STARTED | 0 | 0 | 0 | 9 | 45 | 36 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 8 | 38 | 27 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 1 | 7 | 9 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Treatment Cycle 1, Occurred in Study 120 | ||||||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 16 | 34 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 15 | 33 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Period Title: Treatment Cycle 1, Occurred in Study 120 | ||||||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 4 | 4 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 4 | 4 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | OnabotulinumtoxinA 50 U | OnabotulinumtoxinA 100 U | OnabotulinumtoxinA 200 U | Total |
|---|---|---|---|---|
| Arm/Group Description | 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). | 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). | Following treatment with onabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) intramuscular injection into the detrusor wall in Study 120, participants were eligible for retreatments in this study as needed with a minimum 12-week interval between doses for a maximum of 3 retreatments. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | Total of all reporting groups |
| Overall Participants | 31 | 39 | 25 | 95 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
11.7
(3.49)
|
10.8
(3.36)
|
11.7
(3.22)
|
11.3
(3.36)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
17
54.8%
|
14
35.9%
|
13
52%
|
44
46.3%
|
| Male |
14
45.2%
|
25
64.1%
|
12
48%
|
51
53.7%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
22
71%
|
28
71.8%
|
18
72%
|
68
71.6%
|
| Black or African American |
6
19.4%
|
3
7.7%
|
2
8%
|
11
11.6%
|
| Asian |
1
3.2%
|
2
5.1%
|
0
0%
|
3
3.2%
|
| Hispanic |
1
3.2%
|
3
7.7%
|
3
12%
|
7
7.4%
|
| Other |
1
3.2%
|
3
7.7%
|
2
8%
|
6
6.3%
|
Outcome Measures
| Title | Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 1 |
|---|---|
| Description | 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. |
| Time Frame | Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1 |
Outcome Measure Data
| Analysis Population 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 120. Number analyzed is the number of participants with evaluable data at the given timepoint. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 31 | 39 | 25 |
| Baseline |
2.66
(0.876)
|
2.97
(1.135)
|
3.99
(5.492)
|
| Change from Baseline to Week 6 |
-1.19
(1.156)
|
-1.39
(1.585)
|
-2.19
(5.738)
|
| Title | Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 2 |
|---|---|
| Description | 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. |
| Time Frame | Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2 |
Outcome Measure Data
| Analysis Population 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 120. Number analyzed is the number of participants with evaluable data at the given time point. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 9 | 45 | 36 |
| Baseline |
2.57
(0.937)
|
2.80
(0.915)
|
3.83
(4.623)
|
| Change from Baseline to Week 6 |
-1.07
(2.092)
|
-1.70
(1.331)
|
-1.64
(1.906)
|
| Title | Change From Study Baseline in the Daily Normalized Daytime Average Number of Urinary Incontinence Episodes in Treatment Cycle 3 |
|---|---|
| Description | 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. |
| Time Frame | Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3 |
Outcome Measure Data
| Analysis Population 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 120. Number analyzed is the number of participants with evaluable data at the given time point. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 5 | 16 | 34 |
| Baseline |
2.48
(0.228)
|
2.94
(0.923)
|
3.80
(4.678)
|
| Change from Baseline to Week 6 |
-1.92
(0.858)
|
-1.73
(1.057)
|
-2.74
(4.833)
|
| Title | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Treatment Emergent Adverse Events (STEAEs) |
|---|---|
| Description | 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. |
| Time Frame | First injection on Day 1 in Study 120 through completion of Study 121 (Up to 108 weeks) |
Outcome Measure Data
| Analysis Population 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 120. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) | OnabotulinumtoxinA 50 U (Treatment Cycle 4) | OnabotulinumtoxinA 100 U (Treatment Cycle 4) | OnabotulinumtoxinA 200 U (Treatment Cycle 4) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 31 | 39 | 25 | 9 | 45 | 36 | 5 | 16 | 34 | 3 | 4 | 4 |
| TEAEs |
23
74.2%
|
31
79.5%
|
19
76%
|
7
7.4%
|
34
NaN
|
31
NaN
|
4
NaN
|
10
NaN
|
21
NaN
|
3
NaN
|
2
NaN
|
4
NaN
|
| STEAEs |
2
6.5%
|
3
7.7%
|
1
4%
|
0
0%
|
5
NaN
|
6
NaN
|
0
NaN
|
1
NaN
|
2
NaN
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 31 | 39 | 25 |
| ≥50% Reduction from Baseline to Week 6 |
53.3
171.9%
|
55.6
142.6%
|
52.2
208.8%
|
| ≥75% Reduction from Baseline to Week 6 |
30.0
96.8%
|
41.7
106.9%
|
39.1
156.4%
|
| ≥90% Reduction from Baseline to Week 6 |
26.7
86.1%
|
30.6
78.5%
|
30.4
121.6%
|
| ≥100% Reduction from Baseline to Week 6 |
26.7
86.1%
|
27.8
71.3%
|
26.1
104.4%
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 9 | 45 | 36 |
| ≥50% Reduction from Baseline to Week 6 |
66.7
215.2%
|
65.9
169%
|
58.8
235.2%
|
| ≥75% Reduction from Baseline to Week 6 |
50.0
161.3%
|
43.2
110.8%
|
47.1
188.4%
|
| ≥90% Reduction from Baseline to Week 6 |
50.0
161.3%
|
27.3
70%
|
41.2
164.8%
|
| ≥100% Reduction from Baseline to Week 6 |
50.0
161.3%
|
25.0
64.1%
|
38.2
152.8%
|
| Title | 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 |
|---|---|
| Description | 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. |
| Time Frame | Study Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 5 | 16 | 34 |
| ≥50% Reduction from Baseline at Week 6 |
60.0
193.5%
|
75.0
192.3%
|
69.7
278.8%
|
| ≥75% Reduction from Baseline at Week 6 |
60.0
193.5%
|
37.5
96.2%
|
39.4
157.6%
|
| ≥90% Reduction from Baseline at Week 6 |
60.0
193.5%
|
18.8
48.2%
|
33.3
133.2%
|
| ≥100% Reduction from Baseline at Week 6 |
60.0
193.5%
|
18.8
48.2%
|
30.3
121.2%
|
| Title | Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 1 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 30 | 36 | 21 |
| Mean (Standard Deviation) [mL] |
14.68
(88.146)
|
39.88
(72.787)
|
96.90
(120.429)
|
| Title | Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 2 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 6 | 43 | 31 |
| Mean (Standard Deviation) [mL] |
7.92
(148.597)
|
79.53
(106.794)
|
35.34
(98.209)
|
| Title | Change From Baseline in Average Urine Volume at First Morning Catheterization in Treatment Cycle 3 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Prior to Day 1 in Study 120) to 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 5 | 10 | 31 |
| Mean (Standard Deviation) [mL] |
58.50
(22.749)
|
57.86
(74.762)
|
92.39
(147.322)
|
| Title | Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 1 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 31 | 39 | 25 |
| 0 Nights of Incontinence at Baseline |
0.0
0%
|
15.4
39.5%
|
4.3
17.2%
|
| 0 Nights of Incontinence at Week 6 |
30.0
96.8%
|
37.8
96.9%
|
25.0
100%
|
| 1 Night of Incontinence at Baseline |
12.9
41.6%
|
2.6
6.7%
|
17.4
69.6%
|
| 1 Night of Incontinence at Week 6 |
20.0
64.5%
|
16.2
41.5%
|
29.2
116.8%
|
| 2 Nights of Incontinence at Baseline |
87.1
281%
|
82.1
210.5%
|
78.3
313.2%
|
| 2 Nights of Incontinence at Week 6 |
50.0
161.3%
|
45.9
117.7%
|
45.8
183.2%
|
| Title | Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 2 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 9 | 45 | 36 |
| 0 Nights of Incontinence at Baseline |
0.0
0%
|
8.9
22.8%
|
5.9
23.6%
|
| 0 Nights of Incontinence at Week 6 |
66.7
215.2%
|
34.1
87.4%
|
23.5
94%
|
| 1 Night of Incontinence at Baseline |
22.2
71.6%
|
6.7
17.2%
|
8.8
35.2%
|
| 1 Night of Incontinence at Week 6 |
16.7
53.9%
|
22.7
58.2%
|
8.8
35.2%
|
| 2 Nights of Incontinence at Baseline |
77.8
251%
|
84.4
216.4%
|
85.3
341.2%
|
| 2 Nights of Incontinence at Week 6 |
16.7
53.9%
|
43.2
110.8%
|
67.6
270.4%
|
| Title | Percentage of Participants With Night Time Urinary Incontinence in Treatment Cycle 3 |
|---|---|
| Description | 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. |
| Time Frame | Baseline (Prior to Day 1 in Study 120) and 2 consecutive days in the week prior to Week 6 in Treatment Cycle 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 5 | 16 | 34 |
| 0 Nights of Incontinence at Baseline |
0.0
0%
|
12.5
32.1%
|
5.9
23.6%
|
| 0 Nights of Incontinence at Week 6 |
20.0
64.5%
|
31.3
80.3%
|
21.2
84.8%
|
| 1 Night of Incontinence at Baseline |
0.0
0%
|
0.0
0%
|
5.9
23.6%
|
| 1 Night of Incontinence at Week 6 |
40.0
129%
|
12.5
32.1%
|
27.3
109.2%
|
| 2 Nights of Incontinence at Baseline |
100.0
322.6%
|
87.5
224.4%
|
88.2
352.8%
|
| 2 Nights of Incontinence at Week 6 |
40.0
129%
|
56.3
144.4%
|
51.5
206%
|
| Title | Average Time to Participant's Request for Retreatment |
|---|---|
| Description | 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. |
| Time Frame | First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U | OnabotulinumtoxinA 100 U | OnabotulinumtoxinA 200 U |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). |
| Measure Participants | 30 | 53 | 35 |
| Median (Full Range) [weeks] |
24.55
|
24.64
|
25.43
|
| Title | Average Time to Participant's Qualification for Retreatment |
|---|---|
| Description | 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. |
| Time Frame | First injection on Day 1 in Study 120 through to the date of completion of Study 121 (Up to 108 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U | OnabotulinumtoxinA 100 U | OnabotulinumtoxinA 200 U |
|---|---|---|---|
| Arm/Group Description | 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). | 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). | 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). |
| Measure Participants | 29 | 53 | 25 |
| Median (95% Confidence Interval) [weeks] |
25.38
|
25.43
|
26.29
|
| Title | Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 1 |
|---|---|
| Description | 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. |
| Time Frame | Week 6 in Treatment Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 30 | 35 | 24 |
| Number (95% Confidence Interval) [percentage of participants] |
80.0
258.1%
|
80.0
205.1%
|
75.0
300%
|
| Title | Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 2 |
|---|---|
| Description | 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. |
| Time Frame | Week 6 in Treatment Cycle 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 8 | 42 | 30 |
| Number (95% Confidence Interval) [percentage of participants] |
75.0
241.9%
|
97.6
250.3%
|
83.3
333.2%
|
| Title | Percentage of Participants With Positive Response on Modified Treatment Benefit Scale (TBS) in Treatment Cycle 3 |
|---|---|
| Description | 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. |
| Time Frame | Week 6 in Treatment Cycle 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) |
|---|---|---|---|
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). |
| Measure Participants | 5 | 15 | 33 |
| Number (95% Confidence Interval) [percentage of participants] |
100
322.6%
|
80.0
205.1%
|
84.8
339.2%
|
Adverse Events
| Time Frame | First injection on Day 1 in Study 120 through the completion of Study 121 (Up to 108 Weeks) | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting 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. | |||||||||||||||||||||||
| Arm/Group Title | OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) | OnabotulinumtoxinA 50 U (Treatment Cycle 4) | OnabotulinumtoxinA 100 U (Treatment Cycle 4) | OnabotulinumtoxinA 200 U (Treatment Cycle 4) | ||||||||||||
| Arm/Group Description | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 1. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 2. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 200 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 3. Participants were eligible for retreatment after Week 12 if qualified. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 50 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (botulinum toxin Type A) 100 U (not to exceed 6 U/kg) injected into the detrusor wall on Day 1 in Treatment Cycle 4. Blinded dose increases (one level) were allowed based on clinical response from cycle to cycle (not to exceed 6 U/kg). | OnabotulinumtoxinA (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). | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) | OnabotulinumtoxinA 50 U (Treatment Cycle 4) | OnabotulinumtoxinA 100 U (Treatment Cycle 4) | OnabotulinumtoxinA 200 U (Treatment Cycle 4) | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) | OnabotulinumtoxinA 50 U (Treatment Cycle 4) | OnabotulinumtoxinA 100 U (Treatment Cycle 4) | OnabotulinumtoxinA 200 U (Treatment Cycle 4) | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/31 (6.5%) | 3/39 (7.7%) | 1/25 (4%) | 0/9 (0%) | 5/45 (11.1%) | 6/36 (16.7%) | 0/5 (0%) | 1/16 (6.3%) | 2/34 (5.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Infections and infestations | ||||||||||||||||||||||||
| Urinary tract infection | 1/31 (3.2%) | 2/39 (5.1%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 2/36 (5.6%) | 0/5 (0%) | 0/16 (0%) | 2/34 (5.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Encephalitis viral | 0/31 (0%) | 1/39 (2.6%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Pyelonephritis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 2/45 (4.4%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Bacterial diarrhoea | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Gastroenteritis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Bronchitis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Febrile infection | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Pneumonia | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Wound infection | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Arteriovenous fistula thrombosis | 1/31 (3.2%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Joint dislocation | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Fistula | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Hip deformity | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Foot deformity | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||
| Hydrocephalus | 0/31 (0%) | 1/39 (2.6%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Epilepsy | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Product Issues | ||||||||||||||||||||||||
| Device malfunction | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||||
| Hydronephrosis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Psoriasis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Vascular disorders | ||||||||||||||||||||||||
| Hypertension | 0/31 (0%) | 0/39 (0%) | 1/25 (4%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| OnabotulinumtoxinA 50 U (Treatment Cycle 1) | OnabotulinumtoxinA 100 U (Treatment Cycle 1) | OnabotulinumtoxinA 200 U (Treatment Cycle 1) | OnabotulinumtoxinA 50 U (Treatment Cycle 2) | OnabotulinumtoxinA 100 U (Treatment Cycle 2) | OnabotulinumtoxinA 200 U (Treatment Cycle 2) | OnabotulinumtoxinA 50 U (Treatment Cycle 3) | OnabotulinumtoxinA 100 U (Treatment Cycle 3) | OnabotulinumtoxinA 200 U (Treatment Cycle 3) | OnabotulinumtoxinA 50 U (Treatment Cycle 4) | OnabotulinumtoxinA 100 U (Treatment Cycle 4) | OnabotulinumtoxinA 200 U (Treatment Cycle 4) | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 21/31 (67.7%) | 31/39 (79.5%) | 16/25 (64%) | 7/9 (77.8%) | 32/45 (71.1%) | 27/36 (75%) | 4/5 (80%) | 10/16 (62.5%) | 19/34 (55.9%) | 3/3 (100%) | 2/4 (50%) | 4/4 (100%) | ||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Diarrhoea | 2/31 (6.5%) | 2/39 (5.1%) | 2/25 (8%) | 1/9 (11.1%) | 2/45 (4.4%) | 3/36 (8.3%) | 1/5 (20%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Abdominal pain | 2/31 (6.5%) | 1/39 (2.6%) | 1/25 (4%) | 1/9 (11.1%) | 3/45 (6.7%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Nausea | 2/31 (6.5%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Vomiting | 0/31 (0%) | 2/39 (5.1%) | 0/25 (0%) | 2/9 (22.2%) | 2/45 (4.4%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Constipation | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 3/45 (6.7%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| General disorders | ||||||||||||||||||||||||
| Pyrexia | 1/31 (3.2%) | 5/39 (12.8%) | 0/25 (0%) | 0/9 (0%) | 6/45 (13.3%) | 3/36 (8.3%) | 0/5 (0%) | 0/16 (0%) | 3/34 (8.8%) | 0/3 (0%) | 1/4 (25%) | 1/4 (25%) | ||||||||||||
| Suprapubic pain | 2/31 (6.5%) | 0/39 (0%) | 1/25 (4%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Infections and infestations | ||||||||||||||||||||||||
| Urinary tract infection | 9/31 (29%) | 13/39 (33.3%) | 5/25 (20%) | 1/9 (11.1%) | 22/45 (48.9%) | 6/36 (16.7%) | 0/5 (0%) | 4/16 (25%) | 6/34 (17.6%) | 1/3 (33.3%) | 1/4 (25%) | 0/4 (0%) | ||||||||||||
| Bacteriuria | 5/31 (16.1%) | 7/39 (17.9%) | 5/25 (20%) | 1/9 (11.1%) | 9/45 (20%) | 2/36 (5.6%) | 0/5 (0%) | 3/16 (18.8%) | 4/34 (11.8%) | 2/3 (66.7%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Pharyngitis | 3/31 (9.7%) | 4/39 (10.3%) | 0/25 (0%) | 0/9 (0%) | 3/45 (6.7%) | 2/36 (5.6%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 1/4 (25%) | ||||||||||||
| Nasopharyngitis | 0/31 (0%) | 1/39 (2.6%) | 4/25 (16%) | 0/9 (0%) | 2/45 (4.4%) | 3/36 (8.3%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 1/4 (25%) | ||||||||||||
| Gastroenteritis | 1/31 (3.2%) | 3/39 (7.7%) | 0/25 (0%) | 2/9 (22.2%) | 2/45 (4.4%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Bronchitis | 0/31 (0%) | 3/39 (7.7%) | 1/25 (4%) | 1/9 (11.1%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Cystitis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 1/9 (11.1%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Gastroenteritis viral | 0/31 (0%) | 0/39 (0%) | 1/25 (4%) | 1/9 (11.1%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Viral infection | 1/31 (3.2%) | 1/39 (2.6%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 2/36 (5.6%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Tinea capitis | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 1/9 (11.1%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Sinusitis | 2/31 (6.5%) | 0/39 (0%) | 1/25 (4%) | 0/9 (0%) | 2/45 (4.4%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Asymptomatic bacteriuria | 1/31 (3.2%) | 2/39 (5.1%) | 0/25 (0%) | 1/9 (11.1%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Influenza | 0/31 (0%) | 2/39 (5.1%) | 1/25 (4%) | 0/9 (0%) | 4/45 (8.9%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 1/4 (25%) | ||||||||||||
| Upper respiratory tract infection | 0/31 (0%) | 2/39 (5.1%) | 1/25 (4%) | 0/9 (0%) | 2/45 (4.4%) | 2/36 (5.6%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Procedural pain | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 2/36 (5.6%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Eschar | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 1/9 (11.1%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Foot fracture | 1/31 (3.2%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Skin laceration | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Investigations | ||||||||||||||||||||||||
| Blood urine present | 0/31 (0%) | 2/39 (5.1%) | 0/25 (0%) | 2/9 (22.2%) | 4/45 (8.9%) | 2/36 (5.6%) | 2/5 (40%) | 1/16 (6.3%) | 5/34 (14.7%) | 2/3 (66.7%) | 2/4 (50%) | 2/4 (50%) | ||||||||||||
| Protein urine present | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 2/36 (5.6%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Back pain | 1/31 (3.2%) | 2/39 (5.1%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Neck pain | 0/31 (0%) | 1/39 (2.6%) | 0/25 (0%) | 1/9 (11.1%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||
| Headache | 2/31 (6.5%) | 7/39 (17.9%) | 2/25 (8%) | 1/9 (11.1%) | 3/45 (6.7%) | 2/36 (5.6%) | 2/5 (40%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Renal and urinary disorders | ||||||||||||||||||||||||
| Leukocyturia | 1/31 (3.2%) | 3/39 (7.7%) | 3/25 (12%) | 2/9 (22.2%) | 1/45 (2.2%) | 3/36 (8.3%) | 1/5 (20%) | 0/16 (0%) | 0/34 (0%) | 1/3 (33.3%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Haematuria | 1/31 (3.2%) | 1/39 (2.6%) | 1/25 (4%) | 1/9 (11.1%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Hydronephrosis | 2/31 (6.5%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 2/34 (5.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||||
| Testicular retraction | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 1/4 (25%) | ||||||||||||
| Dysmenorrhoea | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/16 (6.3%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Cough | 2/31 (6.5%) | 1/39 (2.6%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 1/36 (2.8%) | 0/5 (0%) | 0/16 (0%) | 2/34 (5.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Oropharyngeal pain | 0/31 (0%) | 2/39 (5.1%) | 1/25 (4%) | 0/9 (0%) | 5/45 (11.1%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 1/34 (2.9%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Rhinorrhoea | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 2/36 (5.6%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Nasal congestion | 1/31 (3.2%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 0/45 (0%) | 1/36 (2.8%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Acne | 2/31 (6.5%) | 1/39 (2.6%) | 1/25 (4%) | 0/9 (0%) | 0/45 (0%) | 0/36 (0%) | 0/5 (0%) | 0/16 (0%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
| Rash | 0/31 (0%) | 0/39 (0%) | 0/25 (0%) | 0/9 (0%) | 1/45 (2.2%) | 0/36 (0%) | 0/5 (0%) | 1/16 (6.3%) | 0/34 (0%) | 0/3 (0%) | 0/4 (0%) | 0/4 (0%) | ||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Therapeutic Area, Head |
|---|---|
| Organization | Allergan |
| Phone | 714-246-4500 |
| clinicaltrials@allergan.com |
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT01852058
Other Study ID Numbers:
- 191622-121
- 2012-004898-30
First Posted:
May 13, 2013
Last Update Posted:
May 12, 2020
Last Verified:
Apr 1, 2020