Trial Outcomes & Findings for Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence (NCT NCT00910845)
NCT ID: NCT00910845
Last Updated: 2013-03-05
Results Overview
A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
557 participants
Primary outcome timeframe
Baseline, Week 12
Results posted on
2013-03-05
Participant Flow
Participant milestones
| Measure |
onabotulinumtoxinA
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
|---|---|---|
|
Treatment Cycle 1
STARTED
|
280
|
277
|
|
Treatment Cycle 1
COMPLETED
|
249
|
243
|
|
Treatment Cycle 1
NOT COMPLETED
|
31
|
34
|
|
Treatment Cycle 2
STARTED
|
141
|
212
|
|
Treatment Cycle 2
COMPLETED
|
136
|
203
|
|
Treatment Cycle 2
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Baseline characteristics by cohort
| Measure |
onabotulinumtoxinA
n=280 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
n=277 Participants
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
Total
n=557 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 40 years
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Customized
Between 40 and 64 years
|
150 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
293 Participants
n=206 Participants
|
|
Age, Customized
Between 65 and 74 years
|
75 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Age, Customized
≥ 75 years
|
46 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
252 Participants
n=99 Participants
|
245 Participants
n=107 Participants
|
497 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population included all randomized patients.
A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Outcome measures
| Measure |
onabotulinumtoxinA
n=280 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
n=277 Participants
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
|---|---|---|
|
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Baseline
|
5.47 Incontinence episodes
Standard Deviation 3.621
|
5.09 Incontinence episodes
Standard Deviation 3.204
|
|
Change From Baseline in Number of Daily Episodes of Urinary Incontinence
Change from Baseline at Week 12
|
-2.65 Incontinence episodes
Standard Deviation 3.333
|
-0.87 Incontinence episodes
Standard Deviation 2.833
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population included all randomized patients.
The number of micturition episodes (the number of times a patient urinates into the toilet) was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the Baseline and prior to the Week 12 study visit. A negative number change from baseline indicates a reduction in micturition episodes (improvement).
Outcome measures
| Measure |
onabotulinumtoxinA
n=280 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
n=277 Participants
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
|---|---|---|
|
Change From Baseline in Number of Daily Micturition Episodes
Change from Baseline at Week 12
|
-2.15 micturition episodes
Standard Deviation 2.933
|
-0.91 micturition episodes
Standard Deviation 2.577
|
|
Change From Baseline in Number of Daily Micturition Episodes
Baseline
|
11.98 micturition episodes
Standard Deviation 4.259
|
11.20 micturition episodes
Standard Deviation 3.070
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: Intent-to-treat population included all randomized patients.
The total volume voided was measured over one 24-hour period in the week prior to the Baseline and Week 12 study visit and recorded by the patient in the bladder diary. This was used to calculate volume voided per micturition. A positive number change from baseline indicates an increase in volume voided per micturition (improvement).
Outcome measures
| Measure |
onabotulinumtoxinA
n=280 Participants
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
n=277 Participants
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
|---|---|---|
|
Change From Baseline in Volume Voided Per Micturition
Baseline
|
156.4 milliliters
Standard Deviation 63.21
|
161.1 milliliters
Standard Deviation 68.65
|
|
Change From Baseline in Volume Voided Per Micturition
Change from Baseline at Week 12
|
41.1 milliliters
Standard Deviation 87.58
|
9.7 milliliters
Standard Deviation 59.02
|
Adverse Events
onabotulinumtoxinA
Serious events: 18 serious events
Other events: 155 other events
Deaths: 0 deaths
Placebo/onabotulinumtoxinA
Serious events: 16 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
onabotulinumtoxinA
n=278 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
n=272 participants at risk
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Cardiac disorders
Myocardial infarction
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Congenital, familial and genetic disorders
Foramen magnum stenosis
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Ear and labyrinth disorders
Vertigo
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Gastrointestinal disorders
Colitis
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Gastrointestinal disorders
Volvulus
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Pneumonia
|
0.72%
2/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Diverticulitis
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Abscess limb
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Appendiceal abscess
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Folliculitis
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Abscess
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.74%
2/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Metabolism and nutrition disorders
Obesity
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
1.1%
3/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Psychiatric disorders
Depression
|
0.72%
2/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Psychiatric disorders
Bipolar disorder
|
0.36%
1/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.00%
0/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
Other adverse events
| Measure |
onabotulinumtoxinA
n=278 participants at risk
OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
|
Placebo/onabotulinumtoxinA
n=272 participants at risk
Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
24.5%
68/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
9.2%
25/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Infections and infestations
Bacteriuria
|
8.3%
23/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
3.7%
10/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Renal and urinary disorders
Dysuria
|
14.4%
40/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
9.9%
27/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Renal and urinary disorders
Urinary retention
|
5.8%
16/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
0.37%
1/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
|
Renal and urinary disorders
Haematuria
|
2.9%
8/278
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
5.9%
16/272
The safety population was used to calculate the number of participants at risk for Serious Adverse Events (SAEs) and Adverse Events (AEs) and is the total number of patients who were treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER