Trial Outcomes & Findings for Oxybutynin Chloride in Managing Hot Flashes (NCT NCT02961790)
NCT ID: NCT02961790
Last Updated: 2020-01-18
Results Overview
Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Baseline up to day 49
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
High-dose Oxybutynin Chloride Group
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
High-dose Placebo Group
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Placebo Group
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
24
|
25
|
|
Overall Study
COMPLETED
|
35
|
40
|
18
|
20
|
|
Overall Study
NOT COMPLETED
|
15
|
11
|
6
|
5
|
Reasons for withdrawal
| Measure |
High-dose Oxybutynin Chloride Group
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
High-dose Placebo Group
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Placebo Group
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|---|
|
Overall Study
Canceled
|
4
|
5
|
1
|
4
|
|
Overall Study
without baseline data
|
4
|
0
|
1
|
0
|
|
Overall Study
without post baseline data
|
7
|
6
|
4
|
1
|
Baseline Characteristics
Oxybutynin Chloride in Managing Hot Flashes
Baseline characteristics by cohort
| Measure |
High-dose Oxybutynin Chloride Group
n=35 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=40 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
High-dose Placebo Group
n=18 Participants
Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Placebo Group
n=20 Participants
Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
55.6 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
57.5 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 8.7 • n=4 Participants
|
57.1 years
STANDARD_DEVIATION 8.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
113 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
ECOG Performance Status
0
|
33 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
ECOG Performance Status
1
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline up to day 49Population: Patients who received high-dose oxybutynin, low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.
Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity.
Outcome measures
| Measure |
High-dose Oxybutynin Chloride Group
n=31 Participants
Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=34 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
n=35 Participants
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo
|
-16.9 score on a scale
Standard Deviation 15.6
|
-10.6 score on a scale
Standard Deviation 7.7
|
-5.7 score on a scale
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline up to day 49Population: Patients who received low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose oxybutynin chloride group.
Average change in Hot Flash Score from Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration \< 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the low-dose oxybutynin and placebo groups.
Outcome measures
| Measure |
High-dose Oxybutynin Chloride Group
n=34 Participants
Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=35 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo
|
8.1 score on a scale
Standard Error 0.63
|
15.6 score on a scale
Standard Error 0.66
|
—
|
SECONDARY outcome
Timeframe: Baseline up to day 49Population: Patients who received higher dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the high-dose oxybutynin chloride group.
Average change in Hot Flash Score from Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration \< 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the high-dose oxybutynin and placebo groups.
Outcome measures
| Measure |
High-dose Oxybutynin Chloride Group
n=31 Participants
Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=35 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo
|
9.8 score on a scale
Standard Error 0.82
|
16.2 score on a scale
Standard Error 0.82
|
—
|
SECONDARY outcome
Timeframe: Baseline up to day 49Population: Patients who completed baseline and week 7 Symptom Experience Questionnaire Stomach pain/cramps item were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.
Average Change of severity of Stomach pain/cramps symptoms as measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo The Symptom Experience Questionnaire stomach pain/cramps item ("Over the past week, have you experienced stomach pain or cramps?") is scored from 0 to 10 with higher values being worse symptoms. So a negative value means the symptom is improving and a positive score means the symptom is getting worse.
Outcome measures
| Measure |
High-dose Oxybutynin Chloride Group
n=31 Participants
Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=35 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
n=36 Participants
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo
|
0.0 change in score on a scale
Standard Deviation 1.3
|
-0.3 change in score on a scale
Standard Deviation 1.5
|
-1.4 change in score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline up to day 49Population: Patients who completed the Hot Flash-Related Daily Interference Scale (HFRDIS) Work item at baseline and week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.
Average Change of daily interference (Work) from baseline to Week 7 as measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) comparing Low dose oxybutynin vs Placebo and High dose oxybutynin vs Placebo. HFRDIS Work item ("Work (work outside the home and housework)") Interference scores run from 0 to 10 with 0 being no interference and 10 being complete interference.
Outcome measures
| Measure |
High-dose Oxybutynin Chloride Group
n=29 Participants
Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=30 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
n=32 Participants
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo
|
-2.3 change in score on a scale
Standard Deviation 3.4
|
-2.9 change in score on a scale
Standard Deviation 3.2
|
-0.2 change in score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Up to 7 weeksPopulation: Patients who received at least one cycle of treatment and were assessed for adverse events were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups.
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.
Outcome measures
| Measure |
High-dose Oxybutynin Chloride Group
n=45 Participants
Patients receive higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=48 Participants
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
n=44 Participants
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4)
grades 4/5
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
High-dose Oxybutynin Chloride Group
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Low-dose Oxybutynin Chloride Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High-dose Oxybutynin Chloride Group
n=46 participants at risk
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=48 participants at risk
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
n=44 participants at risk
Patients receive placebo regardless of dose level in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
4.3%
2/46 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
Other adverse events
| Measure |
High-dose Oxybutynin Chloride Group
n=46 participants at risk
Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
|
Low-dose Oxybutynin Chloride Group
n=48 participants at risk
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity.
|
Placebo Group
n=44 participants at risk
Patients receive placebo regardless of dose level in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Eye disorders
Blurred vision
|
6.5%
3/46 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Eye disorders
Dry eye
|
6.5%
3/46 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Eye disorders
Eye disorders - Other, specify
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/46 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
9.1%
4/44 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Gastrointestinal disorders
Dry mouth
|
30.4%
14/46 • Number of events 41 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
20.8%
10/48 • Number of events 26 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
6.8%
3/44 • Number of events 7 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
General disorders
Fatigue
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Infections and infestations
Skin infection
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
1/46 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Nervous system disorders
Concentration impairment
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Nervous system disorders
Dizziness
|
6.5%
3/46 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Nervous system disorders
Headache
|
2.2%
1/46 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
6.2%
3/48 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Nervous system disorders
Somnolence
|
2.2%
1/46 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Renal and urinary disorders
Urinary retention
|
8.7%
4/46 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.2%
1/46 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/48 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.3%
1/44 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
|
Vascular disorders
Flushing
|
0.00%
0/46 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
2.1%
1/48 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
0.00%
0/44 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place