Trial Outcomes & Findings for A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO) (NCT NCT02092181)
NCT ID: NCT02092181
Last Updated: 2021-08-16
Results Overview
The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
7-82 days. From visit 2 (baseline) to visit 4
Results posted on
2021-08-16
Participant Flow
Subjects who have met exclusion criteria.
Participant milestones
| Measure |
Mirabegron
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)
Baseline characteristics by cohort
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age,mean
|
66 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7-82 days. From visit 2 (baseline) to visit 4The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Change in the Mean Daily Overactive Bladder-Symptom Composite Score.
|
-3.2 units on a scale
Standard Deviation 8.4
|
-8.9 units on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: baseline (7-14 days post visit 1), visit 3( 32-40 days post visit 2) and visit 4(74-82 days post visit 2)Overactive Bladder questionnaire symptom severity scale (OAB-q), Visit 3 and Visit 4 vs. baseline Scale ranges from 8 to 48 the higher score indicating worse symptoms.
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
Week 3/baseline
|
-4.14 units on a scale
Standard Deviation 5.2
|
-3.2 units on a scale
Standard Deviation 4.8
|
|
Overactive Bladder Questionnaire Symptom Severity Scale( OAB-q)
Week4/baseline
|
-2.6 units on a scale
Standard Deviation 7.9
|
-8.6 units on a scale
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)Non-Motor Symptoms Scale (NMSS), which includes questions about 9 different categories of non-motor symptoms in PD, including urinary symptoms; Visit 3 and Visit 4 vs. baseline. Symptoms assessed over the last month. The scale ranges from 0 to 360, with higher scores indicating worse symptoms.
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Non- Motor Symptoms Scale (NMSS)
visit 3/baseline
|
-7.5 units on a scale
Standard Deviation 15.4
|
-19.6 units on a scale
Standard Deviation 18.9
|
|
Non- Motor Symptoms Scale (NMSS)
visit 4/baseline
|
-10.5 units on a scale
Standard Deviation 18.5
|
-17.9 units on a scale
Standard Deviation 23
|
SECONDARY outcome
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)Patient Perception of Bladder Condition at Visit 3 and Visit 4 vs. baseline. the scale ranges from 1 to 6 with higher score indicating worse outcome
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Patient Perception of Bladder Condition
V3/baseline
|
-0.35 units on a scale
Standard Deviation 2.09
|
-0.7 units on a scale
Standard Deviation 0.5
|
|
Patient Perception of Bladder Condition
V4/baseline
|
-0.38 units on a scale
Standard Deviation 1.9
|
-1.2 units on a scale
Standard Deviation 2.18
|
SECONDARY outcome
Timeframe: baseline (7-14 days post visit 1), visit 3 (32-40 days post visit 2) and visit 4 (74-82 days post visit 2)Subject's Global Impression of Change at Visit 3 and Visit 4 vs. baseline the scale ranges from 0 to 7 with higher score indicating worse out come .
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Subjects Global Impression of Change
visit 3/baseline
|
3.5 units on a scale
Standard Deviation 1.8
|
3.0 units on a scale
Standard Deviation 1.3
|
|
Subjects Global Impression of Change
visit 4/baseline
|
3.5 units on a scale
Standard Deviation 2.2
|
2.6 units on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (7-14 days post visit 1) and visit 3 (32-40 days post visit 2)The primary outcome measure will be the change in the mean daily Overactive Bladder-Symptom Composite Score (OAB-SCS) from baseline (visit 2) to visit 4. The Over active Bladder- Symptom Composite Score requires subjects to record the severity of urgency of each micturition over a 72 hour period. Subject ratings ranges from 1 to 6 for each micturition as follows: 1. Not at all, 2.A little bit, 3.Somewhat 4.Quite a bit, 5. A great deal, 6. A very great deal. Maximum score depends on number of micturition episodes in the 72 hour period, as the rating of each episode is summed to get the total score. Higher scores indicate worse symptoms of overactive bladder.
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Change in Mean Daily OAB-SCS Visit 3 vs Baseline
visit 3 (32-40 days post visit 2
|
3.5 units on a scale
Standard Deviation 1.8
|
3.07 units on a scale
Standard Deviation 1.3
|
|
Change in Mean Daily OAB-SCS Visit 3 vs Baseline
baseline (7-14 days post visit 1)
|
3.5 units on a scale
Standard Deviation 2.2
|
2.6 units on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline vs visit 3 (32-40 days post baseline) and baseline vs. visit 4 ((74-82 days post visit 2)Subjects recorded in a 72-hour micturition diary the number of episodes of urinary incontinence, and this is averaged per 24 hours. Higher scores indicate more episodes of incontinence and thus worse outcome.
Outcome measures
| Measure |
Mirabegron
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 Participants
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Change in Mean Number of Incontinence Episodes Per 24 Hours
V3 vs baseline
|
-0.06 episodes per 24 hrs
Standard Deviation 0.82
|
-0.11 episodes per 24 hrs
Standard Deviation 1.0
|
|
Change in Mean Number of Incontinence Episodes Per 24 Hours
V4/baseline
|
0.12 episodes per 24 hrs
Standard Deviation 1.24
|
-0.61 episodes per 24 hrs
Standard Deviation 1.9
|
Adverse Events
Mirabegron
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mirabegron
n=15 participants at risk
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 participants at risk
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Psychiatric disorders
Psychosis
|
0.00%
0/15 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/15 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/15 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
Other adverse events
| Measure |
Mirabegron
n=15 participants at risk
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
Placebo
n=15 participants at risk
1:1 randomization to receive Mirabegron 25 mg daily or placebo at visit 2. At visit 3 all subjects who have tolerated Mirabegron 25 md daily (no adverse events on this dose) will be up-titrated to Mirabegron 50 mg daily. This will be dispensed as two 25mg tablets or , for those in the placebo arm, two placebo tablets.
Mirabegron: 25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
Placebo: Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
|
|---|---|---|
|
Nervous system disorders
Extreme Dyskinesia
|
0.00%
0/15 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
|
Infections and infestations
Cold symptons
|
0.00%
0/15 • Three months
|
13.3%
2/15 • Number of events 2 • Three months
|
|
Musculoskeletal and connective tissue disorders
Falls
|
0.00%
0/15 • Three months
|
13.3%
2/15 • Number of events 2 • Three months
|
|
Cardiac disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 2 • Three months
|
0.00%
0/15 • Three months
|
|
Nervous system disorders
Hallucinations
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Skin and subcutaneous tissue disorders
itchy/swollenhands
|
0.00%
0/15 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
|
Ear and labyrinth disorders
sinus infection
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Musculoskeletal and connective tissue disorders
foot or knee pain
|
6.7%
1/15 • Number of events 1 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
|
Vascular disorders
Erectile dysfunction
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Skin and subcutaneous tissue disorders
edema
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Nervous system disorders
headache
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Ear and labyrinth disorders
Sore throat
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Cardiac disorders
Heart palpitations
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Renal and urinary disorders
urinary incontinence
|
13.3%
2/15 • Number of events 2 • Three months
|
0.00%
0/15 • Three months
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
|
Gastrointestinal disorders
loose stools
|
13.3%
2/15 • Number of events 2 • Three months
|
0.00%
0/15 • Three months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 3 • Three months
|
0.00%
0/15 • Three months
|
|
Gastrointestinal disorders
abdominal cramps
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • Number of events 1 • Three months
|
0.00%
0/15 • Three months
|
|
Gastrointestinal disorders
Heartbun
|
0.00%
0/15 • Three months
|
6.7%
1/15 • Number of events 1 • Three months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place