Trial Outcomes & Findings for Investigation of Brain Mechanisms Involved in Urgency Urinary Incontinence (NCT NCT04227184)
NCT ID: NCT04227184
Last Updated: 2026-04-24
Results Overview
Whether reduction in number of leaks on 3-day bladder diary is at least 50%
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
168 participants
Primary outcome timeframe
Baseline to 12 weeks and baseline to 24 weeks
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Placebo, Then Trospium
Placebo first for 12 weeks followed by Trospium for 12 weeks.
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
Trospium, Then Placebo
Trospium first for 12 weeks followed by Placebo for 12 weeks
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
85
|
|
Overall Study
Reached First MRI
|
78
|
79
|
|
Overall Study
Reached Second MRI (Completed Period 1)
|
66
|
66
|
|
Overall Study
Reached Third MRI (Completed Period 2)
|
61
|
64
|
|
Overall Study
COMPLETED
|
61
|
63
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
Reasons for withdrawal
| Measure |
Placebo, Then Trospium
Placebo first for 12 weeks followed by Trospium for 12 weeks.
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
Trospium, Then Placebo
Trospium first for 12 weeks followed by Placebo for 12 weeks
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
19
|
19
|
|
Overall Study
Found ineligible after randomization before intervention
|
3
|
3
|
Baseline Characteristics
Some participants who were randomized did not complete the baseline bladder diary.
Baseline characteristics by cohort
| Measure |
Placebo/Trospium
n=83 Participants
Placebo first for 12 weeks followed by Trospium for 12 weeks.
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
Trospium/Placebo
n=85 Participants
Trospium first for 12 weeks followed by Placebo for 12 weeks
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
Total
n=168 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
83 Participants
n=83 Participants
|
85 Participants
n=85 Participants
|
168 Participants
n=168 Participants
|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 6.0 • n=83 Participants
|
68.4 years
STANDARD_DEVIATION 6.1 • n=85 Participants
|
68.4 years
STANDARD_DEVIATION 6.0 • n=168 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=83 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=168 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=83 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=168 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
82 Participants
n=83 Participants
|
85 Participants
n=85 Participants
|
167 Participants
n=168 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=83 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=83 Participants
|
1 Participants
n=85 Participants
|
2 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=83 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=83 Participants
|
9 Participants
n=85 Participants
|
15 Participants
n=168 Participants
|
|
Race (NIH/OMB)
White
|
74 Participants
n=83 Participants
|
74 Participants
n=85 Participants
|
148 Participants
n=168 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=83 Participants
|
1 Participants
n=85 Participants
|
1 Participants
n=168 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=83 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=168 Participants
|
|
Region of Enrollment
United States
|
83 participants
n=83 Participants
|
85 participants
n=85 Participants
|
168 participants
n=168 Participants
|
|
Mean number of leaks per day on three day bladder diary
|
3.63 leaks per day
STANDARD_DEVIATION 2.50 • n=77 Participants • Some participants who were randomized did not complete the baseline bladder diary.
|
3.84 leaks per day
STANDARD_DEVIATION 2.20 • n=75 Participants • Some participants who were randomized did not complete the baseline bladder diary.
|
3.73 leaks per day
STANDARD_DEVIATION 2.35 • n=152 Participants • Some participants who were randomized did not complete the baseline bladder diary.
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks and baseline to 24 weeksPopulation: Analysis was based on bladder diary data which was missing for some participants. While the study design is technically a cross-over design, it differs from a standard cross-over design. The design does not involve a washout period after the drug administration, as part of the design is to assess reversion of symptoms. The goal was not to compare treatment to placebo, but to provide a framework for the mechanistic study, and the outcomes are reported in a way that reflects that.
Whether reduction in number of leaks on 3-day bladder diary is at least 50%
Outcome measures
| Measure |
Placebo/Trospium
n=83 Participants
Placebo first for 12 weeks followed by Trospium for 12 weeks.
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
Trospium/Placebo
n=85 Participants
Trospium first for 12 weeks followed by Placebo for 12 weeks
Trospium: Drug to treat overactive bladder
Placebo oral tablet: Placebo tablet containing no active drug
|
|---|---|---|
|
Responder (Yes/no)
0-12 weeks
|
23 Participants
|
39 Participants
|
|
Responder (Yes/no)
0 to 24 weeks
|
36 Participants
|
17 Participants
|
Adverse Events
Trospium
Serious events: 4 serious events
Other events: 83 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trospium
n=157 participants at risk
Trospium: Drug to treat overactive bladder
AEs from participants taking trospium from both arms
|
Placebo
n=157 participants at risk
Placebo oral tablet: Placebo tablet containing no active drug
AEs from participants taking placebo from both arms
|
|---|---|---|
|
Infections and infestations
Shingles
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Cardiac disorders
Coronary stent placement
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
General disorders
Fever
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Infections and infestations
Sepsis
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Stomach pain
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
General disorders
Swelling of legs
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
Other adverse events
| Measure |
Trospium
n=157 participants at risk
Trospium: Drug to treat overactive bladder
AEs from participants taking trospium from both arms
|
Placebo
n=157 participants at risk
Placebo oral tablet: Placebo tablet containing no active drug
AEs from participants taking placebo from both arms
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
constipation
|
19.7%
31/157 • Number of events 31 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
2.5%
4/157 • Number of events 4 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Eye disorders
Dry eye
|
5.7%
9/157 • Number of events 9 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Dry mouth
|
42.7%
67/157 • Number of events 67 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
4.5%
7/157 • Number of events 7 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Nervous system disorders
headache
|
1.9%
3/157 • Number of events 3 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Renal and urinary disorders
urinary retention
|
4.5%
7/157 • Number of events 7 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MRI brain abnormal
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Immune system disorders
Allergic reaction
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
General disorders
Fatigue
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Anal itching
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Injury, poisoning and procedural complications
Bee sting hypersensitivity
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
1.3%
2/157 • Number of events 2 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary bladder polyp
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Nervous system disorders
Somnolence
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
General disorders
Vivid dreams
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.64%
1/157 • Number of events 1 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
0.00%
0/157 • Adverse event data were collected from enrollment in the study (signing the consent form), to the final MRI visit (approximately 24 weeks)
Participants were asked during telephone calls up to 3 times per period, and at in person visits at the end of each period, if they experienced any side effects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place