Trial Outcomes & Findings for An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants (NCT NCT00613327)
NCT ID: NCT00613327
Last Updated: 2013-11-19
Results Overview
Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
345 participants
Primary outcome timeframe
Week 12
Results posted on
2013-11-19
Participant Flow
Participant milestones
| Measure |
Oxybutynin Chloride OROS
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Overall Study
STARTED
|
345
|
|
Overall Study
COMPLETED
|
244
|
|
Overall Study
NOT COMPLETED
|
101
|
Reasons for withdrawal
| Measure |
Oxybutynin Chloride OROS
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
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|---|---|
|
Overall Study
Adverse Event
|
38
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Other
|
47
|
Baseline Characteristics
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Baseline characteristics by cohort
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
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|---|---|
|
Age Continuous
|
54.93 Years
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
256 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Missing data at Week 12 were imputed using last observation carried forward (LOCF).
Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
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|---|---|
|
Percentage of Participants Who Achieved Treatment Goal
|
40.45 Percentage of participants
Interval 34.93 to 46.16
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=275 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Strongly, Week 12: Slightly
|
41 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Strongly, Week 12: Average
|
40 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Strongly, Week 12: Strongly
|
16 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Strongly, Week 12: Very strongly
|
5 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Very strongly, Week 12: Not bothered
|
5 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Very strongly, Week 12: Slightly
|
14 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Very strongly, Week 12: Average
|
4 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Very strongly, Week 12: Strongly
|
4 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Very strongly, Week 12: Very strongly
|
6 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Not bothered, Week 12: Not bothered
|
1 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Not bothered, Week 12: Slightly
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Not bothered, Week 12: Average
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Not bothered, Week 12: Strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Not bothered, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Slightly, Week 12: Not bothered
|
17 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Slightly, Week 12: Slightly
|
29 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Slightly, Week 12: Average
|
12 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Slightly, Week 12: Strongly
|
6 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Slightly, Week 12: Very strongly
|
1 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Average, Week 12: Not bothered
|
13 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Average, Week 12: Slightly
|
22 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Average, Week 12: Average
|
17 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Average, Week 12: Strongly
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Average, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
Baseline: Strongly, Week 12: Not bothered
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=275 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Not bothered, Week 12: Not bothered
|
3 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Not bothered, Week 12: Slightly
|
3 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Not bothered, Week 12: Average
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Not bothered, Week 12: Strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Not bothered, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Slightly, Week 12: Not bothered
|
7 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Slightly, Week 12: Slightly
|
15 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Slightly, Week 12: Average
|
10 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Slightly, Week 12: Strongly
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Slightly, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Average, Week 12: Not bothered
|
19 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Average, Week 12: Slightly
|
22 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Average, Week 12: Average
|
21 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Average, Week 12: Strongly
|
6 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Average, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Strongly, Week 12: Not bothered
|
21 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Strongly, Week 12: Slightly
|
36 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Strongly, Week 12: Average
|
36 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Strongly, Week 12: Strongly
|
22 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Strongly, Week 12: Very strongly
|
4 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Very strongly, Week 12: Not bothered
|
4 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Very strongly, Week 12: Slightly
|
17 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Very strongly, Week 12: Average
|
12 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Very strongly, Week 12: Strongly
|
12 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
Baseline: Very strongly, Week 12: Very strongly
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime \[period from time of going to bed to time planned to wake up in the morning\]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=276 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Not bothered, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Not bothered, Week 12: Not bothered
|
15 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Not bothered, Week 12: Slightly
|
3 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Not bothered, Week 12: Average
|
1 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Not bothered, Week 12: Strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Slightly, Week 12: Not bothered
|
18 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Slightly, Week 12: Slightly
|
22 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Slightly, Week 12: Average
|
8 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Slightly, Week 12: Strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Slightly, Week 12: Very strongly
|
1 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Average, Week 12: Not bothered
|
17 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Average, Week 12: Slightly
|
24 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Average, Week 12: Average
|
22 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Average, Week 12: Strongly
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Average, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Strongly, Week 12: Not bothered
|
16 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Strongly, Week 12: Slightly
|
32 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Strongly, Week 12: Average
|
23 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Strongly, Week 12: Strongly
|
18 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Strongly, Week 12: Very strongly
|
3 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Very strongly, Week 12: Not bothered
|
6 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Very strongly, Week 12: Slightly
|
23 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Very strongly, Week 12: Average
|
7 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Very strongly, Week 12: Strongly
|
11 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
Baseline: Very strongly, Week 12: Very strongly
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=276 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Not bothered, Week 12: Not bothered
|
63 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Not bothered, Week 12: Slightly
|
7 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Not bothered, Week 12: Average
|
5 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Not bothered, Week 12: Strongly
|
3 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Not bothered, Week 12: Very strongly
|
3 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Slightly, Week 12: Not bothered
|
28 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Slightly, Week 12: Slightly
|
19 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Slightly, Week 12: Average
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Slightly, Week 12: Strongly
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Slightly, Week 12: Very strongly
|
1 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Average, Week 12: Not bothered
|
19 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Average, Week 12: Slightly
|
13 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Average, Week 12: Average
|
7 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Average, Week 12: Strongly
|
2 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Average, Week 12: Very strongly
|
0 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Strongly, Week 12: Not bothered
|
14 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Strongly, Week 12: Slightly
|
22 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Strongly, Week 12: Average
|
13 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Strongly, Week 12: Strongly
|
10 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Strongly, Week 12: Very strongly
|
1 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Very strongly, Week 12: Not bothered
|
15 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Very strongly, Week 12: Slightly
|
17 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Very strongly, Week 12: Average
|
4 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Very strongly, Week 12: Strongly
|
5 Participants
|
|
Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
Baseline: Very strongly, Week 12: Very strongly
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure.
Participant's perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=275 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder
|
38.66 Units on a scale
Standard Deviation 29.73
|
SECONDARY outcome
Timeframe: Week 2, 4, 6 and 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.
The PPTB was used to assess participant's perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=303 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 6, Weak benefit (n=252)
|
135 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 12, Missing (n=277)
|
1 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction:Week 6,Slightly unsatisfactory(n=251)
|
23 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 2, Weak benefit (n=303)
|
184 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 2, Strong benefit (n=303)
|
45 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 2, No benefit (n=303)
|
73 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 2, Missing (n=303)
|
1 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 4, Weak benefit (n=281)
|
155 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 4, Strong benefit (n=281)
|
86 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 4, No benefit (n=281)
|
39 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 4, Missing (n=281)
|
1 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 6, Strong benefit (n=252)
|
97 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 6, No benefit (n=252)
|
19 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 6, Missing (n=252)
|
1 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 12, Weak benefit (n=277)
|
117 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 12, Strong benefit (n=277)
|
127 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Benefit: Week 12, No benefit (n=277)
|
32 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 2,Slightly satisfactory(n=302)
|
168 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 2,Very satisfactory(n=302)
|
27 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction:Week 2,Slightly unsatisfactory(n=302)
|
52 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 2, Very unsatisfactory (n=302)
|
55 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 4,Slightly satisfactory(n=282)
|
160 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 4, Very satisfactory (n=282)
|
57 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction:Week 4,Slightly unsatisfactory(n=282)
|
37 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 4, Very unsatisfactory (n=282)
|
26 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 4, Missing (n=282)
|
2 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 6,Slightly satisfactory(n=251)
|
140 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 6, Very satisfactory (n=251)
|
68 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 6, Very unsatisfactory (n=251)
|
19 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 6, Missing (n=251)
|
1 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 12,Slightly satisfactory(n=277)
|
136 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 12, Very satisfactory (n=277)
|
87 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction:Week12,Slightly unsatisfactory(n=277)
|
19 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 12, Very unsatisfactory (n=277)
|
34 Participants
|
|
Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
Satisfaction: Week 12, Missing (n=277)
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.
Participant's perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Baseline: Not problematic at all (n=309)
|
0 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Week 12: Moderate problem (n=275)
|
63 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Baseline: Mild problem (n=309)
|
4 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Baseline: More or less a mild problem (n=309)
|
25 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Baseline: Moderate problem (n=309)
|
81 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Baseline: Severe problem (n=309)
|
137 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Baseline:Very severe problem (n=309)
|
62 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Week 12: Not problematic at all (n=275)
|
20 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Week 12: Mild problem (n=275)
|
66 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Week 12: More or less a mild problem (n=275)
|
85 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Week 12: Severe problem (n=275)
|
30 Participants
|
|
Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
Week 12: Very severe problem (n=275)
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or early discontinuation (ED)Population: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point.
The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as (\[Actual total raw score - lowest possible value of raw score\]/range)\*100 for symptom bother where higher score indicates greater symptom bother and as (\[Highest possible raw score-Actual total raw score\]/Raw score range)\*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
Symptom bother: Baseline (n=309)
|
50.08 Units on a scale
Standard Deviation 21.61
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
Symptom bother: Change at Week 6 (n=251)
|
-23.73 Units on a scale
Standard Deviation 22.63
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
Symptom bother: Change at Week 12/ED (n=276)
|
-25.63 Units on a scale
Standard Deviation 23.68
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
HRQL: Baseline (n=309)
|
53.46 Units on a scale
Standard Deviation 21.20
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
HRQL: Change at Week 6 (n=251)
|
18.96 Units on a scale
Standard Deviation 19.11
|
|
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
HRQL: Change at Week 12/ED (n=276)
|
21.32 Units on a scale
Standard Deviation 22.01
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.
Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Mean Voiding Frequency
Daytime: Baseline (n=309)
|
10.75 Urinations per day
Standard Deviation 3.71
|
|
Mean Voiding Frequency
Daytime: Week 6 (n=244)
|
8.22 Urinations per day
Standard Deviation 2.78
|
|
Mean Voiding Frequency
Daytime: Week 12/ED (n=245)
|
8.08 Urinations per day
Standard Deviation 3.55
|
|
Mean Voiding Frequency
Nighttime: Baseline (n=309)
|
1.96 Urinations per day
Standard Deviation 1.75
|
|
Mean Voiding Frequency
Nighttime: Week 6 (n=244)
|
1.34 Urinations per day
Standard Deviation 1.04
|
|
Mean Voiding Frequency
Nighttime: Week 12/ED (n=245)
|
1.26 Urinations per day
Standard Deviation 1.40
|
|
Mean Voiding Frequency
Total: Baseline (n=309)
|
12.71 Urinations per day
Standard Deviation 4.56
|
|
Mean Voiding Frequency
Total: Week 6 (n=244)
|
9.56 Urinations per day
Standard Deviation 3.20
|
|
Mean Voiding Frequency
Total: Week 12/ED (n=245)
|
9.34 Urinations per day
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.
Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)\*100.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
Daytime: Percent change at Week 6 (n=244)
|
-20.36 Percent change
Standard Deviation 22.15
|
|
Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
Daytime: Percent change at Week 12/ED (n=245)
|
-22.47 Percent change
Standard Deviation 25.76
|
|
Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
Nighttime: Percent change at Week 6 (n=223)
|
-13.91 Percent change
Standard Deviation 80.74
|
|
Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
Nighttime:Percent change at Week 12/ED (n=224)
|
-21.54 Percent change
Standard Deviation 80.72
|
|
Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
Total: Percent change at Week 6 (n=244)
|
-22.19 Percent change
Standard Deviation 19.40
|
|
Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
Total: Percent change at Week 12/ED (n=245)
|
-24.90 Percent change
Standard Deviation 22.06
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.
Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Frequency of Urinary Urgency and Urinary Incontinence
UI: Week 12/ED (n=245)
|
0.224 Episodes per day
Standard Deviation 1.203
|
|
Frequency of Urinary Urgency and Urinary Incontinence
Urinary urgency: Baseline (n=309)
|
9.40 Episodes per day
Standard Deviation 5.28
|
|
Frequency of Urinary Urgency and Urinary Incontinence
Urinary urgency: Week 6 (n=244)
|
5.11 Episodes per day
Standard Deviation 4.25
|
|
Frequency of Urinary Urgency and Urinary Incontinence
Urinary urgency: Week 12/ED (n=245)
|
4.31 Episodes per day
Standard Deviation 4.48
|
|
Frequency of Urinary Urgency and Urinary Incontinence
UI: Baseline (n=309)
|
0.911 Episodes per day
Standard Deviation 3.244
|
|
Frequency of Urinary Urgency and Urinary Incontinence
UI: Week 6 (n=244)
|
0.213 Episodes per day
Standard Deviation 0.959
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories.
Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)\*100.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=309 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12
Urinary urgency: Percent change at Week 6 (n=244)
|
-39.16 Percent change
Standard Deviation 72.56
|
|
Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12
Urinary urgency:Percent change at Week12/ED(n=245)
|
-46.19 Percent change
Standard Deviation 80.39
|
|
Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12
UI: Percent change at Week 6 (n=75)
|
-56.42 Percent change
Standard Deviation 107.15
|
|
Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12
UI: Percent change at Week 12/ED (n=75)
|
-74.64 Percent change
Standard Deviation 57.92
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: Data was reported in individual participant listings as planned, but not statistically summarized for analysis.
Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.
Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth).
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=308 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Visual Analogue Scale (VAS) Score for Dry Mouth
Baseline (n=308)
|
20.30 Units on a scale
Standard Deviation 22.37
|
|
Visual Analogue Scale (VAS) Score for Dry Mouth
Week 6 (n=250)
|
46.26 Units on a scale
Standard Deviation 26.46
|
|
Visual Analogue Scale (VAS) Score for Dry Mouth
Week 12/ED (n=277)
|
43.85 Units on a scale
Standard Deviation 29.31
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12 or EDPopulation: ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories.
Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)\*100.
Outcome measures
| Measure |
Oxybutynin Chloride OROS
n=308 Participants
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12
Percent change at Week 6 (n=159)
|
210.96 Percent change
Standard Deviation 701.21
|
|
Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12
Percent change at Week 12/ED (n=181)
|
171.90 Percent change
Standard Deviation 475.90
|
Adverse Events
Oxybutynin Chloride OROS
Serious events: 3 serious events
Other events: 289 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxybutynin Chloride OROS
n=320 participants at risk
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Cardiac disorders
Ventricular hypertrophy
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
Other adverse events
| Measure |
Oxybutynin Chloride OROS
n=320 participants at risk
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|---|---|
|
Gastrointestinal disorders
Dry mouth
|
81.6%
261/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.3%
33/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Constipation
|
8.8%
28/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
5.3%
17/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
7/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.94%
3/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Nausea
|
0.94%
3/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Dysuria
|
8.4%
27/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Urine flow decreased
|
2.2%
7/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
4/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Bladder pain
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Urinary hesitation
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Urinary incontinence
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Pyuria
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Renal and urinary disorders
Urethral pain
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Nervous system disorders
Headache
|
4.4%
14/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Nervous system disorders
Somnolence
|
2.2%
7/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Nervous system disorders
Dizziness
|
0.94%
3/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Nervous system disorders
Hypoaesthesia
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Nervous system disorders
Paraesthesia
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
General disorders
Oedema
|
2.5%
8/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
General disorders
Chest discomfort
|
1.6%
5/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
General disorders
Face oedema
|
1.2%
4/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
General disorders
Pyrexia
|
0.94%
3/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
General disorders
Asthenia
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
General disorders
Chest pain
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Eye disorders
Dry eye
|
1.9%
6/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Eye disorders
Vision blurred
|
1.2%
4/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Eye disorders
Xerophthalmia
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Eye disorders
Blepharospasm
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Eye disorders
Cataract
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Eye disorders
Eye pain
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
7/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Acute sinusitis
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Bronchitis
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Cystitis
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Herpes zoster
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Periodontitis
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.2%
4/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
8/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Psychiatric disorders
Insomnia
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Psychiatric disorders
Anxiety
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Psychiatric disorders
Depressed mood
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Psychiatric disorders
Depression
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Psychiatric disorders
Libido decreased
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
2/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Cardiac disorders
Cardiovascular disorder
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Cardiac disorders
Palpitations
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
|
Vascular disorders
Hot flush
|
0.31%
1/320 • Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
|
Additional Information
Clinical Research Associate
Medical Affairs, Janssen Korea
Phone: +82-2-2094-4935
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place