Long Term Follow-up Study of Safety and Efficacy of Botul... | NCT00915525 | Trialant
NCT00915525
Sponsor
Allergan
Status
Completed
Last Update Posted
Apr 30, 2019Actual
Enrollment
829Actual
Phase
Phase 3
Conditions
Overactive Bladder
Urinary Incontinence
Interventions
botulinum toxin Type A
Countries
United States
Belgium
Canada
Czechia
Germany
Poland
Russia
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00915525
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
191622-096
Secondary IDs
Not provided
Brief Title
Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Official Title
Not provided
Acronym
Not provided
Organization
AllerganINDUSTRY
Status Module
Record Verification Date
Apr 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1, 2010Actual
Primary Completion Date
Aug 5, 2014Actual
Completion Date
Aug 5, 2014Actual
First Submitted Date
May 28, 2009
First Submission Date that Met QC Criteria
Jun 4, 2009
First Posted Date
Jun 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 2, 2015
Results First Submitted that Met QC Criteria
Nov 13, 2015
Results First Posted Date
Dec 18, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 18, 2019
Last Update Posted Date
Apr 30, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AllerganINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the long term safety and effectiveness of botulinum toxin type A in treating patients with idiopathic overactive bladder with urinary incontinence.
Detailed Description
Not provided
Conditions Module
Conditions
Overactive Bladder
Urinary Incontinence
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
829Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
botulinum toxin Type A 100U
Experimental
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Biological: botulinum toxin Type A
botulinum toxin Type A 150U
Experimental
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Biological: botulinum toxin Type A
Interventions
Name
Type
Description
Arm Group Labels
Other Names
botulinum toxin Type A
Biological
Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Secondary Outcomes
Measure
Description
Time Frame
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)
Exclusion Criteria:
Females who are pregnant, nursing or planning a pregnancy
Patient has any condition or situation which, in the Investigators opinion, would put the patient at risk from continuing treatment with botulinum toxin Type A
Nitti VW, Ginsberg D, Sievert KD, Sussman D, Radomski S, Sand P, De Ridder D, Jenkins B, Magyar A, Chapple C; 191622-096 Investigators. Durable Efficacy and Safety of Long-Term OnabotulinumtoxinA Treatment in Patients with Overactive Bladder Syndrome: Final Results of a 3.5-Year Study. J Urol. 2016 Sep;196(3):791-800. doi: 10.1016/j.juro.2016.03.146. Epub 2016 Mar 30.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Following a planned interim analysis, the protocol was amended to remove the option to escalate to the 150U dose. The dose groups reflect the highest dose received (i.e. 100U BOTOX includes patients who only received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U at any time during the study).
Recruitment Details
This was a long-term follow-up study that enrolled patients after participation in the preceding studies 191622-095 (NCT00910845) and 191622-520 (NCT00910520). A total of 829 patients received at least 1 BOTOX treatment in Study 191622-096 or in the preceding studies.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
FG001
Botulinum Toxin Type A 150U
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
botulinum toxin Type A 100U
botulinum toxin Type A 150U
BOTOX®
Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 6
Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Week 12 Treatment Cycle 1
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Week 12 Treatment Cycle 2
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Week 12 Treatment Cycle 3
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Week 12 Treatment Cycle 4
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Week 12 Treatment Cycle 5
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
Week 12 Treatment Cycle 6
Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
Study Baseline, Week 12 Treatment Cycle 6
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 1
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 2
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 3
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 4
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 5
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
Study Baseline, Week 12 Treatment Cycle 6
Ghent
Belgium
Victoria
British Columbia
Canada
Prague
Czechia
Tübingen
Germany
Warsaw
Poland
Moscow
Russia
London
United Kingdom
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
FG000543 subjects
FG001286 subjects
COMPLETED
FG000278 subjects
FG001151 subjects
NOT COMPLETED
FG000265 subjects
FG001135 subjects
Type
Comment
Reasons
Protocol Violation
FG0009 subjects
FG0014 subjects
Withdrawal by Subject
FG00059 subjects
FG00121 subjects
Lost to Follow-up
FG00027 subjects
FG00116 subjects
Pregnancy
FG0002 subjects
FG0010 subjects
Lack of Efficacy
FG00015 subjects
FG00132 subjects
Adverse Event
FG00029 subjects
FG00113 subjects
Missing
FG00012 subjects
FG0011 subjects
Other Reason
FG00035 subjects
FG00112 subjects
Site Closed
FG00027 subjects
FG0019 subjects
Retreat Request >Wk 144 (exclusionary)
FG0004 subjects
FG0015 subjects
Study Burden
FG00028 subjects
FG00112 subjects
Non-Compliance
FG0003 subjects
FG0011 subjects
Patient Moved
FG00015 subjects
FG0019 subjects
BOTOX-Treated population includes all patients enrolled in 191622-096 who received at least 1 BOTOX treatment in study 191622-096, 191622-095 or 191622-520. Treatment groups reflect highest dose received (100U BOTOX includes patients who received 100U throughout the study and 150U BOTOX includes patients who received at least 1 dose of 150U).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
BG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000543
BG001286
BG002829
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<40 years
BG00039
BG00123
BG00262
40 to 64 years
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000493
BG001256
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000829
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0005.55± 3.617
Chg from Study BL at Wk 12 Tmt Cycle1 (N=812)
Title
Measurements
OG000-3.26± 3.439
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Primary
Change From Study Baseline in the Daily Average Number of Urinary Incontinence Episodes
Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in incontinence episodes (improvement) and a positive number change from baseline indicates an increase in the number of incontinence episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Primary
Percentage of Patients With a Positive Response on the 4-Point Treatment Benefit Scale (TBS)
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Number
Percentage of Patients
Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Number
Percentage of Patients
Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Number
Percentage of Patients
Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Number
Percentage of Patients
Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Number
Percentage of Patients
Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Primary
Percentage of Patients With a Positive Response on the 4-Point TBS
The TBS is a single-item scale in which the patient considers his/her current condition (urinary problems, urinary incontinence) compared with his/her condition before receiving any study treatment in study 191622-095 or 191622-520. Response options are: 1 = greatly improved; 2 = improved; 3 = not changed; and 4 = worsened. Patients scoring either "greatly improved" or "improved" are considered to have a positive response.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Number
Percentage of Patients
Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the Daily Average Number of Micturition Episodes
The number of micturition (urination) episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of micturition episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in micturition episodes (improvement) and a positive number change from baseline indicates an increase in the number of micturition episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the Urinary Incontinence-Specific Quality of Life (I-QOL) Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Secondary
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Secondary
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Secondary
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Secondary
Change From Study Baseline in the I-QOL Questionnaire Total Summary Score
The I-QOL questionnaire is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure the impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0 = worst QOL and 100= best QOL). The I-QOL total score is calculated by combining the 22-item subscores from the 3 I-QOL domains: Avoidance Limiting Behavior, Psychological Impact, and Social Embarrassment. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate improved QOL and negative changes from baseline indicate worsened QOL
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Secondary
Change From Study Baseline in the King's Health Questionnaire (KHQ) Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Role Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The role limitations domain consists of 2 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in the KHQ Social Limitations Domain
The KHQ is a disease-specific health-related QOL questionnaire that measures urinary incontinence. The social limitations domain consists of 4 questions answered on a 4-point scale (not at all, slightly, moderate, a lot). The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-095 or 191622-520. Positive number changes from baseline indicate a worsening in role limitations and negative number changes from baseline indicate an improvement in role limitations.
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Secondary
Change From Study Baseline in Daily Frequency of Urgency Episodes
The number of urgency episodes are recorded in a patient bladder diary in the 3 consecutive days prior to each study visit for study 191622-096 (or 3 days prior to each visit in study 191622-095 or 191622-520). The number of urgency episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 3 consecutive days prior to the first treatment in either study 191622-095 or 191622-520. A negative number change from baseline indicates a reduction in urgency episodes (improvement) and a positive number change from baseline indicates an increase in the number of urgency episodes (worsening).
BOTOX-Treated Population: all patients with data at the time point who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Number of Episodes
Study Baseline, Week 12 Treatment Cycle 6
ID
Title
Description
OG000
Botulinum Toxin Type A 100U
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
OG001
Botulinum Toxin Type A 150U
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Time Frame
Not provided
Description
BOTOX-Treated Population includes all patients who received at least 1 BOTOX treatment since the start of their clinical study participation (in study 191622-096, 191622-095 or 191622-520), and is used to assess adverse events (AEs) and serious adverse events (SAEs). AEs and SAEs are reported by treatment cycle.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Botulinum Toxin Type A 100U Treatment Cycle 1
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
71
829
297
829
EG001
Botulinum Toxin Type A 100U Treatment Cycle 2
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
62
608
204
608
EG002
Botulinum Toxin Type A 150U Treatment Cycle 2
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
7
116
28
116
EG003
Botulinum Toxin Type A 100U Treatment Cycle 3
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
32
388
135
388
EG004
Botulinum Toxin Type A 150U Treatment Cycle 3
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
13
179
50
179
EG005
Botulinum Toxin Type A 100U Treatment Cycle 4
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
18
273
86
273
EG006
Botulinum Toxin Type A 150U Treatment Cycle 4
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
8
131
34
131
EG007
Botulinum Toxin Type A 100U Treatment Cycle 5
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
15
185
53
185
EG008
Botulinum Toxin Type A 150U Treatment Cycle 5
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
4
88
35
88
EG009
Botulinum Toxin Type A 100U Treatment Cycle 6
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
8
139
43
139
EG010
Botulinum Toxin Type A 150U Treatment Cycle 6
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
3
50
10
50
EG011
Botulinum Toxin Type A 100U Treatment Cycle 7
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
3
93
37
93
EG012
Botulinum Toxin Type A 150U Treatment Cycle 7
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
0
27
16
27
EG013
Botulinum Toxin Type A 100U Treatment Cycle 8
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
4
69
21
69
EG014
Botulinum Toxin Type A 150U Treatment Cycle 8
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
0
11
9
11
EG015
Botulinum Toxin Type A 100U Treatment Cycle 9
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
0
48
18
48
EG016
Botulinum Toxin Type A 150U Treatment Cycle 9
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
0
7
6
7
EG017
Botulinum Toxin Type A 100U Treatment Cycle 10
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
1
37
14
37
EG018
Botulinum Toxin Type A 150U Treatment Cycle 10
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
1
2
1
2
EG019
Botulinum Toxin Type A 100U Treatment Cycle 11
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
2
20
12
20
EG020
Botulinum Toxin Type A 100U Treatment Cycle 12
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
1
5
1
5
EG021
Botulinum Toxin Type A 100U Treatment Cycle 13
Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
0
2
2
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG0030 affected388 at risk
EG0040 affected179 at risk
EG0050 affected273 at risk
EG0060 affected131 at risk
EG0070 affected185 at risk
EG0080 affected88 at risk
EG0090 affected139 at risk
EG0100 affected50 at risk
EG0110 affected93 at risk
EG0120 affected27 at risk
EG0130 affected69 at risk
EG0140 affected11 at risk
EG0150 affected48 at risk
EG0160 affected7 at risk
EG0170 affected37 at risk
EG0180 affected2 at risk
EG0190 affected20 at risk
EG0200 affected5 at risk
EG0210 affected2 at risk
Iron Deficiency Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Supraventricular Tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Cardiac Failure Congestive
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Coronary Artery Disease
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Myocardial Infarction
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Ventricular Tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Abdominal Pain Lower
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Inguinal Hernia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Foramen Magnum Stenosis
Congenital, familial and genetic disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0003 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Appendiceal Abscess
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Comminuted Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pelvic Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Metabolic Acidosis
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0007 affected829 at risk
EG0018 affected608 at risk
EG0020 affected116 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0015 affected608 at risk
EG0020 affected116 at risk
EG003
Breast Cancer Stage II
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Invasive Ductal Breast Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Lung Carcinoma Cell Type Unspecified Stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
MALE ONLY
EG0001 affected80 at risk
EG0010 affected55 at risk
EG0020 affected15 at risk
EG003
Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0001 affected749 at risk
EG0010 affected553 at risk
EG0020 affected101 at risk
EG003
Bulbar Palsy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Carpal Tunnel Syndrome
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Major Depression
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Renal Failure Acute
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Calculus Ureteric
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Urge Incontinence
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
MALE ONLY
EG0001 affected80 at risk
EG0010 affected55 at risk
EG0020 affected15 at risk
EG003
Polycystic Ovaries
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0001 affected749 at risk
EG0010 affected553 at risk
EG0020 affected101 at risk
EG003
Uterine Haemorrhage
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0001 affected749 at risk
EG0011 affected553 at risk
EG0020 affected101 at risk
EG003
Vaginal Prolapse
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0001 affected749 at risk
EG0011 affected553 at risk
EG0020 affected101 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Preventive Surgery
Surgical and medical procedures
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Arterial Thrombosis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Internal Hernia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Large Intestine Polyp
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Chest Pain
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Hernia Obstructive
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Medical Device Complication
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Drug Hypersensitivity
Immune system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Localised infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Lung Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Infected Skin Ulcer
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Staphylococcal Sepsis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Patella Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Procedural Pain
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Stress Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Wound
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Humerus Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Sigmoidoscopy
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Benign Neoplasm of Spinal Cord
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Renal Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Thyroid Adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Bladder Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Cerebral Infarction
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Cerebrovascular Disorder
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Migraine
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Obturator Neuropathy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Restless Legs Syndrome
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Syncope
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Haemorrhage Intracranial
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Depression Suicidal
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Suicide Attempt
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Cystitis Interstitial
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0021 affected116 at risk
EG003
Cervical Polyp
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0000 affected749 at risk
EG0011 affected553 at risk
EG0020 affected101 at risk
EG003
Uterine Prolapse
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0000 affected749 at risk
EG0011 affected553 at risk
EG0020 affected101 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Swelling Face
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Hypotension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0021 affected116 at risk
EG003
Arterial Occlusive Disease
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Thrombosis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Coagulopathy
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Angina Unstable
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Stress Cardiomyopathy
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Congenital Diaphragmatic Hernia
Congenital, familial and genetic disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Upper Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Device Ineffective
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Allergy to Plants
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Anaphylactic Shock
Immune system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Bacterial Sepsis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cystitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Accidental Overdose
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Spinal Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pyogenic Granuloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Benign Ovarian Tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0000 affected749 at risk
EG0010 affected553 at risk
EG0020 affected101 at risk
EG003
Lip Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Carotid Artery Stenosis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cerebral Artery Thrombosis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cervical Radiculopathy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Parkinsonism
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Peroneal Nerve Palsy
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Hydroureter
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pelvi-Ureteric Obstruction
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Vaginal Haemorrhage
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0000 affected749 at risk
EG0010 affected553 at risk
EG0020 affected101 at risk
EG003
Perineal pain
Reproductive system and breast disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Emphysema
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Arterial Disorder
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Temporal Arteritis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Varicose Vein
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Vitreous Floaters
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Wound Dehiscence
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Tendon Disorder
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Malignant Melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Malignant Melanoma in Situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
B-Cell Small Lymphocytic Lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Actinic keratosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Excessive skin
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Skin Ulcer
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Hypertensive Crisis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Mitral Valve Prolapse
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Goitre
Endocrine disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Enterovesical Fistula
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Upper Limb Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Heart Rate Increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Endometrial Hypertrophy
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
FEMALE ONLY
EG0000 affected749 at risk
EG0010 affected553 at risk
EG0020 affected101 at risk
EG003
Arthritis Bacterial
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Glomerulonephritis
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Haematemesis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Squamous Cell Carcinoma of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Radiation Injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Skin Wrinkling
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cardiac Arrest
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Urinary Tract Infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG000225 affected829 at risk
EG001161 affected608 at risk
EG00217 affected116 at risk
EG003107 affected388 at risk
EG00439 affected179 at risk
EG00567 affected273 at risk
EG00628 affected131 at risk
EG00740 affected185 at risk
EG00820 affected88 at risk
EG00928 affected139 at risk
EG0106 affected50 at risk
EG01124 affected93 at risk
EG0124 affected27 at risk
EG0139 affected69 at risk
EG0143 affected11 at risk
EG01513 affected48 at risk
EG0162 affected7 at risk
EG0179 affected37 at risk
EG0181 affected2 at risk
EG0194 affected20 at risk
EG0200 affected5 at risk
EG0211 affected2 at risk
Bacteriuria
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG00070 affected829 at risk
EG00154 affected608 at risk
EG0028 affected116 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG00071 affected829 at risk
EG00147 affected608 at risk
EG0027 affected116 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA 17.0
Non-systematic Assessment
MALE ONLY
EG0000 affected180 at risk
EG0011 affected55 at risk
EG0020 affected15 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG00014 affected829 at risk
EG0019 affected608 at risk
EG0021 affected116 at risk
EG003
Benign Prostatic Hyperplasia
Reproductive system and breast disorders
MedDRA 17.0
Systematic Assessment
MALE ONLY
EG0001 affected80 at risk
EG0010 affected55 at risk
EG0020 affected15 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG00023 affected829 at risk
EG00120 affected608 at risk
EG0022 affected116 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0008 affected829 at risk
EG0018 affected608 at risk
EG0022 affected116 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG00026 affected829 at risk
EG00119 affected608 at risk
EG0022 affected116 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG00012 affected829 at risk
EG0016 affected608 at risk
EG0024 affected116 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG00027 affected829 at risk
EG00126 affected608 at risk
EG0021 affected116 at risk
EG003
Cataract
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0008 affected829 at risk
EG0018 affected608 at risk
EG0020 affected116 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Non-systematic Assessment
EG00013 affected829 at risk
EG00114 affected608 at risk
EG0020 affected116 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG00030 affected829 at risk
EG00117 affected608 at risk
EG0025 affected116 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG00013 affected829 at risk
EG00123 affected608 at risk
EG0025 affected116 at risk
EG003
Acute Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG00016 affected829 at risk
EG00121 affected608 at risk
EG0021 affected116 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG00013 affected829 at risk
EG00116 affected608 at risk
EG0021 affected116 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.0
Non-systematic Assessment
EG0008 affected829 at risk
EG0015 affected608 at risk
EG0020 affected116 at risk
EG003
Cystitis Glandularis
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG00016 affected829 at risk
EG00120 affected608 at risk
EG0021 affected116 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0005 affected829 at risk
EG0017 affected608 at risk
EG0020 affected116 at risk
EG003
Hyperkeratosis
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Swelling Face
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Eye Inflammation
Eye disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG00024 affected829 at risk
EG00114 affected608 at risk
EG0022 affected116 at risk
EG003
Respiratory Tract Infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0002 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Limb Injury
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Spinal Column Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0012 affected608 at risk
EG0020 affected116 at risk
EG003
Benign Neoplasm of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG00010 affected829 at risk
EG00113 affected608 at risk
EG0023 affected116 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG00034 affected829 at risk
EG00123 affected608 at risk
EG0020 affected116 at risk
EG003
Skin Wrinkling
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Radiation Injury
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Type 2 Diabetes Mellitus
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected829 at risk
EG0012 affected608 at risk
EG0021 affected116 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0003 affected829 at risk
EG0019 affected608 at risk
EG0020 affected116 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0006 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG00025 affected829 at risk
EG00112 affected608 at risk
EG0022 affected116 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected829 at risk
EG0014 affected608 at risk
EG0020 affected116 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected829 at risk
EG0014 affected608 at risk
EG0020 affected116 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0003 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Capsular Contracture Associated with Breast Implant
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0008 affected829 at risk
EG0017 affected608 at risk
EG0020 affected116 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Lower Respiratory Tract Infection
Infections and infestations
MedDRA 17.0
Non-systematic Assessment
EG0003 affected829 at risk
EG0014 affected608 at risk
EG0021 affected116 at risk
EG003
Femur Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA 17.0
Non-systematic Assessment
EG0004 affected829 at risk
EG0012 affected608 at risk
EG0021 affected116 at risk
EG003
Residual Urine Volume
Investigations
MedDRA 17.0
Systematic Assessment
EG00026 affected829 at risk
EG00112 affected608 at risk
EG0020 affected116 at risk
EG003
Trigeminal Neuralgia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Bladder Hypertrophy
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0011 affected608 at risk
EG0020 affected116 at risk
EG003
Urine Abnormality
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0002 affected829 at risk
EG0012 affected608 at risk
EG0021 affected116 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Non-systematic Assessment
EG0004 affected829 at risk
EG0013 affected608 at risk
EG0020 affected116 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0005 affected829 at risk
EG0014 affected608 at risk
EG0020 affected116 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 affected829 at risk
EG0012 affected608 at risk
EG0021 affected116 at risk
EG003
Cervical Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Non-systematic Assessment
EG0000 affected829 at risk
EG0010 affected608 at risk
EG0020 affected116 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Point of Contact
Title
Organization
Phone
Extension
Email
Therapeutic Area Head,
Allergan, Inc
714-246-4500
clinicaltrials@allergan.com
ID
Term
D053201
Urinary Bladder, Overactive
D014549
Urinary Incontinence
Ancestor Terms
ID
Term
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D059411
Lower Urinary Tract Symptoms
D020924
Urological Manifestations
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
D014555
Urination Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D019274
Botulinum Toxins, Type A
Ancestor Terms
ID
Term
D001905
Botulinum Toxins
D008666
Metalloendopeptidases
D010450
Endopeptidases
D010447
Peptide Hydrolases
D006867
Hydrolases
D004798
Enzymes
D045762
Enzymes and Coenzymes
D045726
Metalloproteases
D001426
Bacterial Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D001427
Bacterial Toxins
D014118
Toxins, Biological
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
BG000276
BG001147
BG002423
65 to 74 years
BG000156
BG00174
BG002230
≥75 years
BG00072
BG00142
BG002114
749
Male
BG00050
BG00130
BG00280
Units
Counts
Participants
OG000608
OG001116
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0005.70± 3.685
OG0015.66± 3.798
Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108)
Title
Measurements
OG000-3.64± 3.402
OG001-3.05± 3.690
Units
Counts
Participants
OG000388
OG001179
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0005.65± 3.380
OG0016.30± 4.280
Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170)
Title
Measurements
OG000-3.82± 3.341
OG001-3.46± 3.771
Units
Counts
Participants
OG000273
OG001131
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0005.78± 3.463
OG0016.19± 4.140
Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122)
Title
Measurements
OG000-3.48± 3.733
OG001-3.32± 3.972
Units
Counts
Participants
OG000185
OG00188
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0005.47± 3.283
OG0016.43± 3.622
Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85)
Title
Measurements
OG000-3.34± 3.791
OG001-3.58± 3.266
Units
Counts
Participants
OG000139
OG00150
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0005.65± 3.238
OG0017.17± 4.223
Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48)
Title
Measurements
OG000-3.05± 3.493
OG001-3.12± 3.753
812
Title
Denominators
Categories
Title
Measurements
OG00074.0
Counts
Participants
OG000594
OG001110
Title
Denominators
Categories
Title
Measurements
OG00081.3
OG00171.8
Counts
Participants
OG000374
OG001173
Title
Denominators
Categories
Title
Measurements
OG00082.1
OG00171.1
Counts
Participants
OG000263
OG001123
Title
Denominators
Categories
Title
Measurements
OG00078.3
OG00181.3
Counts
Participants
OG000179
OG00186
Title
Denominators
Categories
Title
Measurements
OG00083.2
OG00181.4
Counts
Participants
OG000136
OG00148
Title
Denominators
Categories
Title
Measurements
OG00080.9
OG00181.3
OG000829
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00011.70± 3.584
Chg from Study BL at Wk 12 Tmt Cycle1 (N=812)
Title
Measurements
OG000-2.56± 2.887
Units
Counts
Participants
OG000608
OG001116
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00011.83± 3.634
OG00111.48± 3.912
Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108)
Title
Measurements
OG000-2.89± 3.037
OG001-2.31± 3.293
Units
Counts
Participants
OG000388
OG001179
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00011.65± 3.553
OG00112.22± 3.760
Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170)
Title
Measurements
OG000-2.86± 3.058
OG001-3.01± 3.217
Units
Counts
Participants
OG000273
OG001131
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00011.68± 3.456
OG00111.82± 3.442
Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122)
Title
Measurements
OG000-2.69± 3.485
OG001-2.78± 2.882
Units
Counts
Participants
OG000185
OG00188
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00011.55± 3.261
OG00111.79± 2.770
Chg from Study BL at Wk 12 Tmt Cycle5 (N=181, 85)
Title
Measurements
OG000-2.85± 3.181
OG001-3.19± 2.772
Units
Counts
Participants
OG000139
OG00150
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00011.85± 3.377
OG00111.81± 2.990
Chg from Study BL at Wk 12 Tmt Cycle6 (N=136, 48)
Title
Measurements
OG000-2.76± 3.153
OG001-2.66± 3.351
Units
Counts
Participants
OG000827
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00034.3± 18.58
Chg from Study BL at Wk 12 Tmt Cycle1 (N=810)
Title
Measurements
OG00026.0± 24.84
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000606
OG001116
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00033.8± 18.72
OG00132.8± 17.91
Chg from Study BL at Wk 12 Tmt Cycle2 (N=586, 109)
Title
Measurements
OG00028.6± 24.38
OG00121.6± 23.71
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000386
OG001179
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00033.8± 18.21
OG00131.9± 18.17
Chg from Study BL at Wk 12 Tmt Cycle3 (N=371, 173)
Title
Measurements
OG00027.6± 22.39
OG00123.7± 25.68
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000271
OG001131
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00031.4± 17.32
OG00132.5± 19.36
Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 124)
Title
Measurements
OG00027.3± 24.90
OG00120.3± 22.63
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000184
OG00188
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00031.2± 17.49
OG00131.9± 20.30
Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86)
Title
Measurements
OG00028.1± 23.75
OG00119.5± 21.43
Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Units
Counts
Participants
OG000138
OG00150
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00030.3± 17.87
OG00130.2± 20.28
Chg from Study BL at Wk 12 Tmt Cycle5 (N=178, 86)
Title
Measurements
OG00022.6± 24.99
OG00118.3± 14.91
OG000
824
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00064.3± 28.77
Chg from Study BL at Wk 12 Tmt Cycle1 (N=813)
Title
Measurements
OG000-28.5± 34.32
Units
Counts
Participants
OG000605
OG001115
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00064.5± 28.51
OG00166.2± 30.15
Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109)
Title
Measurements
OG000-32.1± 34.29
OG001-29.2± 35.94
Units
Counts
Participants
OG000387
OG001177
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00064.7± 28.36
OG00163.4± 30.41
Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171)
Title
Measurements
OG000-29.7± 33.47
OG001-27.9± 34.57
Units
Counts
Participants
OG000272
OG001130
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00066.3± 27.65
OG00162.3± 31.17
Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123)
Title
Measurements
OG000-30.9± 33.82
OG001-23.4± 33.05
Units
Counts
Participants
OG000185
OG00187
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00065.4± 29.15
OG00162.6± 31.84
Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85)
Title
Measurements
OG000-30.8± 35.13
OG001-26.3± 28.45
Units
Counts
Participants
OG000138
OG00150
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00066.4± 30.00
OG00160.3± 33.15
Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48)
Title
Measurements
OG000-24.8± 38.93
OG001-22.9± 25.64
824
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00043.1± 30.79
Chg from Study BL at Wk 12 Tmt Cycle1 (N=813)
Title
Measurements
OG000-18.4± 29.46
Units
Counts
Participants
OG000605
OG001115
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00043.0± 30.96
OG00148.4± 30.12
Chg from Study BL at Wk 12 Tmt Cycle2 (N=585, 109)
Title
Measurements
OG000-20.0± 29.12
OG001-19.0± 28.55
Units
Counts
Participants
OG000387
OG001177
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00042.8± 31.02
OG00145.4± 31.38
Chg from Study BL at Wk 12 Tmt Cycle3 (N=373, 171)
Title
Measurements
OG000-17.9± 29.26
OG001-19.2± 28.31
Units
Counts
Participants
OG000272
OG001130
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00044.7± 31.86
OG00143.2± 30.46
Chg from Study BL at Wk 12 Tmt Cycle4 (N=261, 123)
Title
Measurements
OG000-19.8± 31.26
OG001-16.1± 23.17
Units
Counts
Participants
OG000185
OG00187
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00044.4± 31.39
OG00143.4± 32.89
Chg from Study BL at Wk 12 Tmt Cycle5 (N=179, 85)
Title
Measurements
OG000-21.7± 28.47
OG001-15.7± 24.52
Units
Counts
Participants
OG000138
OG00150
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG00046.7± 32.72
OG00143.3± 32.56
Chg from Study BL at Wk 12 Tmt Cycle6 (N=134, 48)
Title
Measurements
OG000-17.0± 33.59
OG001-17.6± 24.43
OG000829
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0008.55± 4.206
Chg from Study BL at Wk 12 Tmt Cycle1 (N=812)
Title
Measurements
OG000-3.81± 4.031
Units
Counts
Participants
OG000608
OG001116
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0008.63± 4.188
OG0019.09± 4.764
Chg from Study BL at Wk 12 Tmt Cycle2 (N=597, 108)
Title
Measurements
OG000-4.07± 4.046
OG001-3.96± 4.519
Units
Counts
Participants
OG000388
OG001179
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0008.62± 4.055
OG0019.28± 4.552
Chg from Study BL at Wk 12 Tmt Cycle3 (N=372, 170)
Title
Measurements
OG000-4.22± 4.120
OG001-3.86± 4.332
Units
Counts
Participants
OG000273
OG001131
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0008.65± 3.951
OG0018.98± 4.241
Chg from Study BL at Wk 12 Tmt Cycle4 (N=264, 122)