A Long-term Follow-up Study of Botulinum Toxin Type A in... | NCT00876447 | Trialant
NCT00876447
Sponsor
Allergan
Status
Completed
Last Update Posted
May 1, 2019Actual
Enrollment
397Actual
Phase
Phase 3
Conditions
Overactive Bladder
Interventions
Botulinum Toxin Type A 300U
Botulinum Toxin Type A 200U
Countries
United States
Australia
Austria
Belgium
Brazil
Canada
Czechia
France
Germany
Italy
Netherlands
New Zealand
Poland
Portugal
Russia
Singapore
Slovakia
South Africa
Spain
Taiwan
Ukraine
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00876447
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
191622-094
Secondary IDs
Not provided
Brief Title
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis
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
Jan 1, 2009Actual
Primary Completion Date
Jun 12, 2013Actual
Completion Date
Sep 4, 2013Actual
First Submitted Date
Apr 1, 2009
First Submission Date that Met QC Criteria
Apr 3, 2009
First Posted Date
Apr 6, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 12, 2014
Results First Submitted that Met QC Criteria
Jun 12, 2014
Results First Posted Date
Jun 13, 2014Estimated
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
May 1, 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 on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).
Detailed Description
Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.
Conditions Module
Conditions
Overactive Bladder
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
397Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Botulinum Toxin Type A 300U
Experimental
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Biological: Botulinum Toxin Type A 300U
Botulinum Toxin Type A 200U
Experimental
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Biological: Botulinum Toxin Type A 200U
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Botulinum Toxin Type A 300U
Biological
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 300U
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Study Baseline, Week 6 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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Study Baseline, Week 6 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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Study Baseline, Week 6 Treatment Cycle 3
Secondary Outcomes
Measure
Description
Time Frame
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:
Patient completed at least 52 weeks in the preceding study.
No longer than 6 months has elapsed since completion of the preceding study
Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.
Exclusion Criteria:
History or evidence of pelvic or urologic abnormality.
Previous or current diagnosis of bladder or prostate cancer.
Kennelly M, Dmochowski R, Schulte-Baukloh H, Ethans K, Del Popolo G, Moore C, Jenkins B, Guard S, Zheng Y, Karsenty G; 191622-094 Investigators. Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. Neurourol Urodyn. 2017 Feb;36(2):368-375. doi: 10.1002/nau.22934. Epub 2015 Nov 24.
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
The protocol was amended to remove the 300 U dose. Patients ongoing in the study who were treated with 300 U BOTOX prior to the amendment were assigned to 200 U BOTOX for all subsequent treatments. Participant Flow and Baseline Characteristics are based on the first BOTOX dose that patients received.
Recruitment Details
This was a long-term follow-up study that enrolled patients after participation in Study 191622-515 or 191622-516. A total of 397 patients were enrolled and 388 patients received at least 1 BOTOX treatment in study 191622-094 or in the preceding studies.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
FG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Botulinum Toxin Type A 200U
BOTOX®
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Study Baseline, Week 6 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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Study Baseline, Week 6 Treatment Cycle 5
Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved QOL.
Study Baseline, Week 6 Treatment Cycle 5
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Study Baseline, Week 6 Treatment Cycle 1
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Study Baseline, Week 6 Treatment Cycle 2
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Study Baseline, Week 6 Treatment Cycle 3
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Study Baseline, Week 6 Treatment Cycle 4
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
Study Baseline, Week 6 Treatment Cycle 5
Randwick
Australia
Innsbruck
Austria
Ghent
Belgium
Rio de Janeiro
Brazil
Victoria
British Columbia
Canada
Ostrava
Czechia
Salouël
France
Kiel
Germany
Florence
Italy
Amsterdam
Netherlands
Epsom
New Zealand
Poznan
Poland
Porto
Portugal
Moscow
Russia
Singapore
Singapore
Prešov
Slovakia
Pretoria
South Africa
Santa Cruz de Tenerife
Spain
Hualien City
Taiwan
Kiev
Ukraine
London
United Kingdom
FG000185 subjects
FG001203 subjects
COMPLETED
FG000105 subjects
FG001122 subjects
NOT COMPLETED
FG00080 subjects
FG00181 subjects
Type
Comment
Reasons
Other miscellaneous reasons
FG0003 subjects
FG0018 subjects
Site closure
FG00019 subjects
FG00114 subjects
Protocol Violation
FG0009 subjects
FG0013 subjects
Personal reasons
FG00030 subjects
FG00128 subjects
Lost to Follow-up
FG0006 subjects
FG00115 subjects
Pregnancy
FG0004 subjects
FG0012 subjects
Lack of Efficacy
FG0005 subjects
FG0013 subjects
Adverse Event
FG0004 subjects
FG0018 subjects
BOTOX-Treated population includes all patients who enrolled in this study and who received at least one BOTOX treatment, regardless of which study they received it in (study 191622-094 or their preceding study 191622-515 or 191622-516). The treatment groups are based on the first BOTOX dose that patients received.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
BG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000185
BG001203
BG002388
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
BG00055
BG00157
BG002112
≥40 to 64 years
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000116
BG001118
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Units
Counts
Participants
OG000183
OG001201
Title
Denominators
Categories
Study Baseline (BL)
Title
Measurements
OG0004.4± 2.54
OG0014.5± 2.64
Chg from Study BL at Wk 6 Tmt Cycle1 (N=176, 195)
Title
Measurements
OG000
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
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 191622-094 (or 7 days prior to each visit in study 191622-515 or 191622-516). The number of incontinence episodes are averaged daily during this period. The initial study baseline is obtained from the patient bladder diary in the 7 consecutive days prior to the first treatment in either study 191622-515 or 191622-516. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Incontinence Episodes
Study Baseline, Week 6 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved 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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 6 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved 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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 6 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved 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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 6 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved 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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 6 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Secondary
Change From Study Baseline in the Incontinence Quality of Life Instrument (I-QOL) 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 191622-515 or 191622-516. Positive number changes from baseline indicate improved 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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Scores on a Scale
Study Baseline, Week 6 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Secondary
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Milliliters (mL)
Study Baseline, Week 6 Treatment Cycle 1
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Units
Secondary
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Milliliters (mL)
Study Baseline, Week 6 Treatment Cycle 2
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Units
Secondary
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Milliliters (mL)
Study Baseline, Week 6 Treatment Cycle 3
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Units
Secondary
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Milliliters (mL)
Study Baseline, Week 6 Treatment Cycle 4
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Units
Secondary
Change From Study Baseline in Volume Per Void
The total volume voided (voluntary or by catheterization) is recorded by the patient over a 24-hour period preceding the study visit. The average volume per voiding episode is derived by dividing the total volume collected in a 24-hour period by the total number of urinary episodes with volume recorded in the same 24-hour period. The initial study baseline is obtained from data collected prior to the first treatment in Study 191622-515 or 191622-516. Positive number changes from baseline indicate improvement.
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 191622-094, 191622-515 or 191622-516); analyses are based on actual treatment received
Posted
Mean
Standard Deviation
Milliliters (mL)
Study Baseline, Week 6 Treatment Cycle 5
ID
Title
Description
OG000
Botulinum Toxin Type A 300U
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
OG001
Botulinum Toxin Type A 200U
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
Units
Time Frame
Not provided
Description
The Botox-Treated Population includes all patients who received at least 1 BOTOX treatment (in Study 191622-094, 191622-515 or 191622-516) 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 300U Treatment Cycle 1
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
28
185
154
185
EG001
Botulinum Toxin Type A 200U Treatment Cycle 1
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
35
203
170
203
EG002
Botulinum Toxin Type A 300U Treatment Cycle 2
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
26
163
126
163
EG003
Botulinum Toxin Type A 200U Treatment Cycle 2
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
21
187
147
187
EG004
Botulinum Toxin Type A 300U Treatment Cycle 3
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
20
119
89
119
EG005
Botulinum Toxin Type A 200U Treatment Cycle 3
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
19
175
123
175
EG006
Botulinum Toxin Type A 300U Treatment Cycle 4
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
11
69
51
69
EG007
Botulinum Toxin Type A 200U Treatment Cycle 4
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
20
153
109
153
EG008
Botulinum Toxin Type A 300U Treatment Cycle 5
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
5
34
19
34
EG009
Botulinum Toxin Type A 200U Treatment Cycle 5
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
11
110
72
110
EG010
Botulinum Toxin Type A 300U Treatment Cycle 6
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
16
8
16
EG011
Botulinum Toxin Type A 200U Treatment Cycle 6
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
9
70
46
70
EG012
Botulinum Toxin Type A 300U Treatment Cycle 7
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
8
3
8
EG013
Botulinum Toxin Type A 200U Treatment Cycle 7
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
6
48
28
48
EG014
Botulinum Toxin Type A 300U Treatment Cycle 8
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
0
0
0
EG015
Botulinum Toxin Type A 200U Treatment Cycle 8
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
0
36
23
36
EG016
Botulinum Toxin Type A 300U Treatment Cycle 9
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
0
0
0
EG017
Botulinum Toxin Type A 200U Treatment Cycle 9
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
2
22
13
22
EG018
Botulinum Toxin Type A 300U Treatment Cycle 10
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
0
0
0
EG019
Botulinum Toxin Type A 200U Treatment Cycle 10
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
1
11
5
11
EG020
Botulinum Toxin Type A 300U Treatment Cycle 11
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
0
0
0
EG021
Botulinum Toxin Type A 200U Treatment Cycle 11
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
0
5
3
5
EG022
Botulinum Toxin Type A 300U Treatment Cycle 12
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
0
0
0
EG023
Botulinum Toxin Type A 200U Treatment Cycle 12
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
0
2
1
2
EG024
Botulinum Toxin Type A 300U Treatment Cycle 13
Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
0
0
0
0
EG025
Botulinum Toxin Type A 200U Treatment Cycle 13
Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
0
1
0
0
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG0030 affected187 at risk
EG0040 affected119 at risk
EG0050 affected175 at risk
EG0060 affected69 at risk
EG0070 affected153 at risk
EG0080 affected34 at risk
EG0090 affected110 at risk
EG0100 affected16 at risk
EG0110 affected70 at risk
EG0120 affected8 at risk
EG0130 affected48 at risk
EG0140 affected0 at risk
EG0150 affected36 at risk
EG0160 affected0 at risk
EG0170 affected22 at risk
EG0180 affected0 at risk
EG0190 affected11 at risk
EG0200 affected0 at risk
EG0210 affected5 at risk
EG0220 affected0 at risk
EG0230 affected2 at risk
EG0240 affected0 at risk
EG0250 affected1 at risk
Myocardial Infarction
Cardiac disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Atrioventricular Block
Cardiac disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0002 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Umbilical Hernia
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Enterocutaneous Fistula
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Adverse Drug Reaction
General disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0012 affected203 at risk
EG0020 affected163 at risk
EG003
Pyrexia
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Cholecystitis Acute
Hepatobiliary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0007 affected185 at risk
EG0015 affected203 at risk
EG0023 affected163 at risk
EG003
Pneumonia
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Urinary Tract Infection Bacterial
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Urosepsis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Wound Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Appendicitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Escherichia Sepsis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Meningitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Necrotising Fasciitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Paronychia
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Sepsis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Craniocerebral Injury
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Tendon Rupture
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0021 affected163 at risk
EG003
Forearm Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Incisional Hernia
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Urine Cytology Abnormal
Investigations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Obesity
Metabolism and nutrition disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Lumbar Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0002 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Spondylolisthesis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Foot Deformity
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Intervertebral Disc Protrusion
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0012 affected203 at risk
EG0020 affected163 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Vertebral Foraminal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0001 affected69 at risk
EG0010 affected85 at risk
EG0020 affected64 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0012 affected203 at risk
EG0020 affected163 at risk
EG003
Squamous Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Thyroid Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Multiple Sclerosis Relapse
Nervous system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0004 affected185 at risk
EG0014 affected203 at risk
EG0024 affected163 at risk
EG003
Muscle Spasticity
Nervous system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Ischaemic Stroke
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Myasthenia Gravis
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Mental Status Changes
Psychiatric disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Urethral Haemorrhage
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Epididymitis
Reproductive system and breast disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected69 at risk
EG0011 affected85 at risk
EG0020 affected64 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0021 affected163 at risk
EG003
Decubitus Ulcer
Skin and subcutaneous tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0002 affected185 at risk
EG0014 affected203 at risk
EG0021 affected163 at risk
EG003
Abortion Induced
Surgical and medical procedures
MedDRA version 16.0
Systematic Assessment
EG0000 affected116 at risk
EG0011 affected118 at risk
EG0020 affected99 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Vision Blurred
Eye disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Colitis Ischaemic
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Haemorrhoidal Haemorrhage
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Large Intestine Perforation
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Lower Gastrointestinal Haemorrhage
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Volvulus
Gastrointestinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Device Dislocation
General disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Oedema Peripheral
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Pyelonephritis Acute
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Systemic Candida
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Localised Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Hip Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Tibia Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Bone Pain
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Lupus-Like Syndrome
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Exostosis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Multiple Sclerosis
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0022 affected163 at risk
EG003
Paraparesis
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Convulsion
Nervous system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Acute Psychosis
Psychiatric disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Stress Urinary Incontinence
Renal and urinary disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Bladder Neck Obstruction
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Urethral Stenosis
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Pelvic Prolapse
Reproductive system and breast disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0021 affected163 at risk
EG003
Peripheral Ischaemia
Vascular disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Atrial Fibrillation
Cardiac disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Device Deployment Issue
General disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Impaired Healing
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Anaphylactic Reaction
Immune system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Abscess of Salivary Gland
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Skin Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Device Related Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Joint Dislocation
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Spinal Compression Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Squamous Cell Carcinoma of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Confusional State
Psychiatric disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Neurogenic Bladder
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Erectile Dysfunction
Reproductive system and breast disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected69 at risk
EG0010 affected85 at risk
EG0020 affected64 at risk
EG003
Pulmonary Embolism
Respiratory, thoracic and mediastinal disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Deep Vein Thrombosis
Vascular disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Peripheral Vascular Disorder
Vascular disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Device Malfunction
General disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Erysipelas
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Parotitis
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Viral Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Scar
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Scrotal Haematoma
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected69 at risk
EG0010 affected85 at risk
EG0020 affected64 at risk
EG003
Cervical Spinal Stenosis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Invasive Ductal Breast Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Cervical myelopathy
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Urinary Incontinence
Renal and urinary disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hydroureter
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Post Procedural Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Post Procedural Haemorrhage
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Medical observation
Investigations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Glioblastoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Spinal Cord Compression
Nervous system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Foot Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Mobility Decreased
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Uterine Leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 16.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected118 at risk
EG0020 affected99 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Subcutaneous Abscess
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Ankle Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0007 affected185 at risk
EG00110 affected203 at risk
EG0027 affected163 at risk
EG0036 affected187 at risk
EG0043 affected119 at risk
EG0050 affected175 at risk
EG0063 affected69 at risk
EG0074 affected153 at risk
EG0082 affected34 at risk
EG0094 affected110 at risk
EG0100 affected16 at risk
EG0114 affected70 at risk
EG0120 affected8 at risk
EG0133 affected48 at risk
EG0140 affected0 at risk
EG0150 affected36 at risk
EG0160 affected0 at risk
EG0170 affected22 at risk
EG0180 affected0 at risk
EG0190 affected11 at risk
EG0200 affected0 at risk
EG0210 affected5 at risk
EG0220 affected0 at risk
EG0230 affected2 at risk
EG0240 affected0 at risk
EG0250 affected0 at risk
Oedema Peripheral
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0006 affected185 at risk
EG0018 affected203 at risk
EG0023 affected163 at risk
EG003
Urinary Tract Infection
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG000100 affected185 at risk
EG001118 affected203 at risk
EG00286 affected163 at risk
EG003
Muscle Spasticity
Nervous system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0004 affected185 at risk
EG0011 affected203 at risk
EG0022 affected163 at risk
EG003
Depression
Psychiatric disorders
MedDRA version 16.0
Non-systematic Assessment
EG0005 affected185 at risk
EG0016 affected203 at risk
EG0023 affected163 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected116 at risk
EG0010 affected118 at risk
EG0020 affected99 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA version 16.0
Non-systematic Assessment
EG00042 affected185 at risk
EG00141 affected203 at risk
EG00213 affected163 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG00010 affected185 at risk
EG0019 affected203 at risk
EG0027 affected163 at risk
EG003
Fatigue
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0006 affected185 at risk
EG00113 affected203 at risk
EG0024 affected163 at risk
EG003
Pyrexia
General disorders
MedDRA version 16.0
Non-systematic Assessment
EG0004 affected185 at risk
EG00117 affected203 at risk
EG0025 affected163 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0004 affected116 at risk
EG0017 affected118 at risk
EG0024 affected99 at risk
EG003
Expanded Disability Status Scale Score Increased
Investigations
MedDRA version 16.0
Systematic Assessment
EG0007 affected185 at risk
EG00110 affected203 at risk
EG00213 affected163 at risk
EG003
Muscular Weakness
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0005 affected185 at risk
EG0018 affected203 at risk
EG00210 affected163 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0005 affected185 at risk
EG0016 affected203 at risk
EG0027 affected163 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0007 affected185 at risk
EG0016 affected203 at risk
EG0023 affected163 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0002 affected185 at risk
EG0011 affected203 at risk
EG0025 affected163 at risk
EG003
Muscle Strain
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0013 affected203 at risk
EG0021 affected163 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0004 affected185 at risk
EG0018 affected203 at risk
EG0027 affected163 at risk
EG003
Fracture Pain
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0012 affected203 at risk
EG0021 affected163 at risk
EG003
Haemoglobin Decreased
Investigations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0001 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0005 affected185 at risk
EG00110 affected203 at risk
EG0023 affected163 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0012 affected203 at risk
EG0022 affected163 at risk
EG003
Vulvovaginal Pruritus
Reproductive system and breast disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected116 at risk
EG0011 affected118 at risk
EG0020 affected99 at risk
EG003
Bundle Branch Block Right
Cardiac disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Central Nervous System Function Test Abnormal
Investigations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Dermatitis Atopic
Skin and subcutaneous tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Fungal Skin Infection
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0012 affected203 at risk
EG0020 affected163 at risk
EG003
Gastroenteritis Norovirus
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Osteomyelitis Acute
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 16.0
Non-systematic Assessment
EG0003 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Rhinitis Seasonal
Respiratory, thoracic and mediastinal disorders
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0010 affected203 at risk
EG0020 affected163 at risk
EG003
Staphylococcal Infection
Infections and infestations
MedDRA version 16.0
Systematic Assessment
EG0000 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Folliculitis
Infections and infestations
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0012 affected203 at risk
EG0020 affected163 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0004 affected185 at risk
EG0015 affected203 at risk
EG0022 affected163 at risk
EG003
Thermal Burn
Injury, poisoning and procedural complications
MedDRA version 16.0
Non-systematic Assessment
EG0000 affected185 at risk
EG0012 affected203 at risk
EG0020 affected163 at risk
EG003
Urine abnormality
Renal and urinary disorders
MedDRA version 16.0
Systematic Assessment
EG0001 affected185 at risk
EG0011 affected203 at risk
EG0020 affected163 at risk
EG003
Headache
Nervous system disorders
MedDRA version 16.0
Non-systematic Assessment
EG0008 affected185 at risk
EG0019 affected203 at risk
EG0023 affected163 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
Ancestor Terms
ID
Term
D001745
Urinary Bladder Diseases
D014570
Urologic Diseases
D052776
Female Urogenital Diseases
D005261
Female Urogenital Diseases and Pregnancy Complications