Trial Outcomes & Findings for Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer (NCT NCT04600336)
NCT ID: NCT04600336
Last Updated: 2025-03-30
Results Overview
Using patients' hot flash diaries, daily hot flash scores will be determined by multiplying the frequency of each defined hot flash grade (mild=1, moderate=2, severe=3, very severe=4) by the severity and summing the values over a 24-hour period. Weekly hot flash scores will be computed by averaging these hot flash scores across 7 days. A score of 0 would mean the patient experienced no hot flashes during the week, and every unit increase reflects more or more severe hot flashes experienced. A mixed model will be estimated that includes baseline and weekly hot flash scores across the 6-week treatment period. Estimates from the mixed model will be used to construct 90% confidence intervals for mean differences in hot flash score reduction from baseline to 6 weeks between the oxybutynin and placebo arms. Contrasts estimated via the mixed model will involve a two-sided t-test with alpha = .10.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
6 weeks post-randomization
Results posted on
2025-03-30
Participant Flow
The placebo arms will be half the size as the oxybutynin arms, as they will be combined to have a placebo group with the same number of patients as the two different treatment groups. This allows all patients to be blinded as to whether they are receiving active drug or a placebo. Patients randomized to the two placebo arms will be combined to form a single placebo arm for analysis.
Participant milestones
| Measure |
Low-dose Oxybutynin
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Oxybutynin Chloride: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Oxybutynin Chloride: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Low-dose Placebo
Patients receive a low-dose placebo (2.5 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose oxybutynin per physician discretion.
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
High-dose Placebo
Patients receive a high-dose placebo (5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - high-dose oxybutynin chloride per physician discretion.
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Initial Treatment
STARTED
|
28
|
28
|
15
|
11
|
|
Initial Treatment
COMPLETED
|
27
|
24
|
14
|
11
|
|
Initial Treatment
NOT COMPLETED
|
1
|
4
|
1
|
0
|
|
Crossover Treatment
STARTED
|
0
|
0
|
11
|
8
|
|
Crossover Treatment
COMPLETED
|
0
|
0
|
8
|
6
|
|
Crossover Treatment
NOT COMPLETED
|
0
|
0
|
3
|
2
|
Reasons for withdrawal
| Measure |
Low-dose Oxybutynin
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Oxybutynin Chloride: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
Oxybutynin Chloride: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Low-dose Placebo
Patients receive a low-dose placebo (2.5 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose oxybutynin per physician discretion.
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
High-dose Placebo
Patients receive a high-dose placebo (5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - high-dose oxybutynin chloride per physician discretion.
Placebo Administration: Given PO
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Initial Treatment
Withdrawal by Subject
|
1
|
2
|
0
|
0
|
|
Initial Treatment
Adverse Event
|
0
|
2
|
0
|
0
|
|
Initial Treatment
Other complicating disease
|
0
|
0
|
1
|
0
|
|
Crossover Treatment
Withdrawal by Subject
|
0
|
0
|
2
|
1
|
|
Crossover Treatment
Adverse Event
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Low-dose Oxybutynin
n=28 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.\>
\> Oxybutynin Chloride: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=28 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.\>
\> Oxybutynin Chloride: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=25 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.\>
\> Placebo Administration: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 7.3 • n=93 Participants
|
68.9 years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
68.8 years
STANDARD_DEVIATION 5.8 • n=27 Participants
|
68.5 years
STANDARD_DEVIATION 6.9 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
78 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
81 Participants
n=483 Participants
|
|
Daily hot flash frequency at baseline
10 or more hot flashes per day
|
17 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Daily hot flash frequency at baseline
4 to 9 hot flashes per day
|
11 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Hot flash duration at baseline
9 or more months
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
35 Participants
n=483 Participants
|
|
Hot flash duration at baseline
less that 9 months
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Number or prior hot flash therapies
0
|
22 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Number or prior hot flash therapies
1 or more
|
6 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post-randomizationPopulation: Patients that began treatment and were eligible were included in analysis
Using patients' hot flash diaries, daily hot flash scores will be determined by multiplying the frequency of each defined hot flash grade (mild=1, moderate=2, severe=3, very severe=4) by the severity and summing the values over a 24-hour period. Weekly hot flash scores will be computed by averaging these hot flash scores across 7 days. A score of 0 would mean the patient experienced no hot flashes during the week, and every unit increase reflects more or more severe hot flashes experienced. A mixed model will be estimated that includes baseline and weekly hot flash scores across the 6-week treatment period. Estimates from the mixed model will be used to construct 90% confidence intervals for mean differences in hot flash score reduction from baseline to 6 weeks between the oxybutynin and placebo arms. Contrasts estimated via the mixed model will involve a two-sided t-test with alpha = .10.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=28 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=28 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=25 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Change in Weekly Patient-reported Hot Flash Scores
|
-9.94 units on a scale
Interval -13.1 to -6.77
|
-13.95 units on a scale
Interval -17.18 to -10.73
|
-4.85 units on a scale
Interval -8.2 to -1.5
|
SECONDARY outcome
Timeframe: 6 weeks post-randomizationPopulation: Patients that began treatment and were eligible were included in analysis.
Weekly hot flash frequencies will be determined by patients' hot flash diaries. A mixed model will be estimated that includes baseline and weekly hot flash frequencies across the 6-week treatment period. The mixed model and subsequent contrasts will account for the observed distribution of weekly hot flash frequencies.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=28 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=28 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=25 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Change in Patient-reported Hot Flash Frequency
|
-4.77 change in hot flashes per day
Interval -6.05 to -3.49
|
-6.89 change in hot flashes per day
Interval -8.19 to -5.58
|
-2.15 change in hot flashes per day
Interval -3.5 to -0.79
|
SECONDARY outcome
Timeframe: 12 weeks post-randomizationPopulation: Patients that began treatment were included in analysis
Grade 3 or higher adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 5.0 and summarized by arm.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=28 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=28 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=26 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Number of Patients That Experienced a Grade 3+ Adverse Event
|
2 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-randomizationPopulation: Patients that began treatment, were eligible, and completed their 6 week PRO questionnaire were included in analysis
Patient-reported symptoms will be assessed by the Symptom Experience Questionnaire. A mixed model will be estimated that includes baseline and weekly patient-reported symptoms across the 6-week treatment period. The mean change in answers from baseline to week 6 to the item "How Distressing Was Your Experience With Hot Flashes" will be reported. Answers are given on a scale from 0 to 10 with higher scores being worse; therefore a positive number indicates a worse experience at week 6.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=27 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=24 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=23 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Patient-reported Symptoms
|
-1.8 average change score from baseline
Standard Deviation 2.74
|
-3.0 average change score from baseline
Standard Deviation 2.68
|
-0.5 average change score from baseline
Standard Deviation 2.61
|
SECONDARY outcome
Timeframe: 26 monthsThe time required to accrue 87 patients will be reported.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=87 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Patient Accrual
|
26 months
|
—
|
—
|
SECONDARY outcome
Timeframe: 4 monthsPopulation: All patients that began treatment and were eligible were included in analysis.
Treatment adherence rates will be calculated by dividing the number of patients who completed treatment per protocol by the number of patients who started treatment. Treatment adherence rates will be summarized by arm.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=28 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=28 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=25 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Patients That Completed Treatment
|
27 Participants
|
24 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 6 weeks post-randomizationPopulation: Patients that began treatment, were eligible, and completed their 6 week HFRDIS questionnaire.
A mixed model will be estimated that includes patients' scores on the Hot Flash Related Daily Interference Scale (HFRDIS) across the 6-week treatment period. The mean change in answers from baseline to week 6 to the item "Overall Quality of Life" will be reported. Answers are given on a scale from 0 to 10 with higher scores being worse; therefore a positive number indicates a worse experience at week 6.
Outcome measures
| Measure |
Low-dose Oxybutynin
n=28 Participants
Patients receive low-dose oxybutynin chloride (2.5 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
High-dose Oxybutynin Chloride
n=28 Participants
Patients receive high-dose oxybutynin chloride (5.0 mL twice daily) PO BID on days 8-49 (6 weeks) in the absence of unacceptable toxicity.
\>
\> Oxybutynin Chloride: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Placebo
n=25 Participants
Patients receive a low-dose or high-dose placebo (2.5 or 5.0 mL twice daily) PO BID on days 8-49 (6 weeks). After 6 weeks, patients may cross over to experimental arm - low-dose or high-dose oxybutynin per physician discretion.
\>
\> Placebo Administration: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|---|
|
Patient-reported Hot Flash Interference
|
-1.0 average change score from baseline
Standard Deviation 2.88
|
-2.4 average change score from baseline
Standard Deviation 1.89
|
0.0 average change score from baseline
Standard Deviation 2.70
|
Adverse Events
Low-dose Oxybutynin - Initial Treatment
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
High-dose Oxybutynin Chloride - Initial Treatment
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Low-dose Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High-dose Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Low-dose Oxybutynin - Crossover Treatment
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
High-dose Oxybutynin Chloride - Crossover Treatment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-dose Oxybutynin - Initial Treatment
n=28 participants at risk
2.5mL oxybutynin
|
High-dose Oxybutynin Chloride - Initial Treatment
n=28 participants at risk
5.0mL oxybutynin
|
Low-dose Placebo
n=15 participants at risk
2.5mL placebo
|
High-dose Placebo
n=11 participants at risk
5.0mL placebo
|
Low-dose Oxybutynin - Crossover Treatment
n=11 participants at risk
2.5mL oxybutynin - crossover treatment
|
High-dose Oxybutynin Chloride - Crossover Treatment
n=8 participants at risk
5.0mL oxybutynin - crossover treatment
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
Other adverse events
| Measure |
Low-dose Oxybutynin - Initial Treatment
n=28 participants at risk
2.5mL oxybutynin
|
High-dose Oxybutynin Chloride - Initial Treatment
n=28 participants at risk
5.0mL oxybutynin
|
Low-dose Placebo
n=15 participants at risk
2.5mL placebo
|
High-dose Placebo
n=11 participants at risk
5.0mL placebo
|
Low-dose Oxybutynin - Crossover Treatment
n=11 participants at risk
2.5mL oxybutynin - crossover treatment
|
High-dose Oxybutynin Chloride - Crossover Treatment
n=8 participants at risk
5.0mL oxybutynin - crossover treatment
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • Number of events 1 • 4 months
|
7.1%
2/28 • Number of events 2 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Eye disorders
Blurred vision
|
14.3%
4/28 • Number of events 15 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Eye disorders
Dry eye
|
3.6%
1/28 • Number of events 2 • 4 months
|
21.4%
6/28 • Number of events 9 • 4 months
|
6.7%
1/15 • Number of events 1 • 4 months
|
0.00%
0/11 • 4 months
|
27.3%
3/11 • Number of events 13 • 4 months
|
0.00%
0/8 • 4 months
|
|
Eye disorders
Eye disorders - Other, specify
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Number of events 5 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 4 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 4 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Constipation
|
10.7%
3/28 • Number of events 5 • 4 months
|
7.1%
2/28 • Number of events 5 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
27.3%
3/11 • Number of events 13 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
4/28 • Number of events 12 • 4 months
|
10.7%
3/28 • Number of events 9 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
18.2%
2/11 • Number of events 7 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Dry mouth
|
35.7%
10/28 • Number of events 34 • 4 months
|
64.3%
18/28 • Number of events 56 • 4 months
|
0.00%
0/15 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
45.5%
5/11 • Number of events 14 • 4 months
|
50.0%
4/8 • Number of events 9 • 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 3 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 4 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
2/28 • Number of events 4 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.6%
1/28 • Number of events 2 • 4 months
|
7.1%
2/28 • Number of events 4 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Nausea
|
28.6%
8/28 • Number of events 20 • 4 months
|
7.1%
2/28 • Number of events 8 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
18.2%
2/11 • Number of events 3 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 6 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Stomach pain
|
10.7%
3/28 • Number of events 3 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Toothache
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
General disorders
Chills
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
General disorders
Edema limbs
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
General disorders
Fatigue
|
17.9%
5/28 • Number of events 12 • 4 months
|
10.7%
3/28 • Number of events 10 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
General disorders
Pain
|
0.00%
0/28 • 4 months
|
7.1%
2/28 • Number of events 2 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Number of events 3 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 8 • 4 months
|
0.00%
0/8 • 4 months
|
|
Investigations
Creatinine increased
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 5 • 4 months
|
0.00%
0/8 • 4 months
|
|
Investigations
Lymphocyte count decreased
|
7.1%
2/28 • Number of events 2 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Investigations
Platelet count decreased
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.6%
1/28 • Number of events 4 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 2 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
7.1%
2/28 • Number of events 3 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.6%
1/28 • Number of events 2 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
18.2%
2/11 • Number of events 12 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Concentration impairment
|
3.6%
1/28 • Number of events 2 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Dizziness
|
17.9%
5/28 • Number of events 21 • 4 months
|
14.3%
4/28 • Number of events 9 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
18.2%
2/11 • Number of events 2 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Headache
|
17.9%
5/28 • Number of events 14 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Nervous system disorders
Memory impairment
|
7.1%
2/28 • Number of events 4 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Paresthesia
|
3.6%
1/28 • Number of events 5 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Nervous system disorders
Somnolence
|
3.6%
1/28 • Number of events 3 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
9.1%
1/11 • Number of events 5 • 4 months
|
0.00%
0/8 • 4 months
|
|
Psychiatric disorders
Insomnia
|
14.3%
4/28 • Number of events 14 • 4 months
|
7.1%
2/28 • Number of events 6 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
25.0%
2/8 • Number of events 2 • 4 months
|
|
Renal and urinary disorders
Dysuria
|
7.1%
2/28 • Number of events 2 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Renal and urinary disorders
Hematuria
|
3.6%
1/28 • Number of events 2 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.1%
2/28 • Number of events 4 • 4 months
|
3.6%
1/28 • Number of events 5 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
4/28 • Number of events 13 • 4 months
|
10.7%
3/28 • Number of events 8 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
2/28 • Number of events 7 • 4 months
|
14.3%
4/28 • Number of events 10 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
4/28 • Number of events 5 • 4 months
|
14.3%
4/28 • Number of events 9 • 4 months
|
6.7%
1/15 • Number of events 3 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 10 • 4 months
|
0.00%
0/8 • 4 months
|
|
Renal and urinary disorders
Urinary urgency
|
7.1%
2/28 • Number of events 9 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Renal and urinary disorders
Urine discoloration
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Reproductive system and breast disorders
Testicular pain
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
3.6%
1/28 • Number of events 5 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
3.6%
1/28 • Number of events 3 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/28 • 4 months
|
3.6%
1/28 • Number of events 1 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/28 • 4 months
|
7.1%
2/28 • Number of events 2 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
18.2%
2/11 • Number of events 4 • 4 months
|
0.00%
0/8 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 8 • 4 months
|
0.00%
0/8 • 4 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/28 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
9.1%
1/11 • Number of events 1 • 4 months
|
0.00%
0/8 • 4 months
|
|
Vascular disorders
Hot flashes
|
0.00%
0/28 • 4 months
|
10.7%
3/28 • Number of events 4 • 4 months
|
6.7%
1/15 • Number of events 1 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
12.5%
1/8 • Number of events 1 • 4 months
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Number of events 6 • 4 months
|
0.00%
0/28 • 4 months
|
0.00%
0/15 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/11 • 4 months
|
0.00%
0/8 • 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place